tag:blogger.com,1999:blog-34348720078715076542024-02-08T05:17:02.803-08:002012 FDA Expected ApprovalsFDA approval calendar 2012
Please help keeping this blog sctive by clicking on some ads on the page.Unknownnoreply@blogger.comBlogger4125tag:blogger.com,1999:blog-3434872007871507654.post-49044431594251936502021-02-27T16:24:00.002-08:002021-02-27T16:57:36.926-08:00FDA Drug Approvals for 2021<p> Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, CDER provides scientific and regulatory advice needed to bring new therapies to market.</p><div class="inset-column"><p><a id="top" name="top"></a></p></div><p>The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.</p><p>Each year, CDER approves a wide range of new drugs and biological products:</p><ul><li>Some of these products are innovative new products that never have been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products approved by CDER in 2021. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2021 by the <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="065c3693-2add-4aa5-96b7-6de0eba8711c" href="https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biological-approvals-year" title="Biological Approvals by Year">Center for Biologics Evaluation and Research</a>.</li><li>Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. See <a href="https://www.accessdata.fda.gov/scripts/cder/daf/">Drugs@FDA</a> for information about all of CDER’s approved drugs and biological products.</li></ul><p>Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.</p><div class="table-responsive"><table border="1" cellpadding="0" cellspacing="0" class="table table-bordered table-striped" style="width: 100%px;" summary="2020 Novel Drugs"><thead><tr><th id="header1" scope="col">No.</th><th id="header2" scope="col">Drug Name</th><th id="header3" scope="col">Active Ingredient</th><th id="header4" scope="col">Approval Date</th><th id="header5" scope="col">FDA-approved use on approval date*</th></tr></thead><tbody><tr><td>8.</td><td>Amondys 45</td><td>casimersen</td><td>2/25/2021</td><td>For the treatment of Duchenne muscular dystrophy</td></tr><tr><td>7.</td><td><a href="http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=214200">Cosela</a></td><td>trilacicilib</td><td>2/12/2021</td><td>To mitigate chemotherapy-induced myelosuppression in adult patients with small cell lung cancer</td></tr><tr><td>6.</td><td><a href="http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761181">Evkeeza</a></td><td>evinacumab-dgnb</td><td>2/11/2021</td><td>For the treatment of homozygous familial hypercholesterolemia</td></tr><tr><td>5.</td><td><a href="http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213176">Ukoniq</a></td><td>umbralisib</td><td>2/5/2021</td><td>For the treatment of certain patients with marginal zone lymphoma and follicular lymphoma</td></tr><tr><td>4.</td><td><a href="http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=214096">Tepmetko</a></td><td>tepotinib</td><td>2/3/2021</td><td>To treat non-small cell lung cancer</td></tr><tr><td>3.</td><td><a href="http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=213716">Lupkynis</a></td><td>voclosporin</td><td>1/22/2021</td><td>To treat lupus nephritis<br /><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="8bb77046-86a0-4266-966d-0e011419758c" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-lupkynis" title="Drug Trials Snapshot: LUPKYNIS">Drug Trials Snapshot</a></td></tr><tr><td>2.</td><td><a href="http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=212888">Cabenuva</a></td><td>cabotegravir and rilpivirine</td><td>1/21/2021</td><td>To treat HIV<br /><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="df7e0d67-e860-4a9c-92d5-6a1d8e42c986" href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-extended-release-injectable-drug-regimen-adults-living-hiv" title="FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV">Press Release</a><br /><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1dc490b1-41e4-4aec-a562-074fc5ec1b0c" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-cabenuva" title="Drug Trials Snapshot: CABENUVA">Drug Trials Snapshot</a></td></tr><tr><td>1.</td><td><a href="http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=214377">Verquvo</a></td><td>vericiguat</td><td>1/19/2021</td><td>To treat chronic heart failure<br /><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="858ed168-687c-4ed4-a8b3-4fb36976a078" href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-verquvo" title="Drug Trials Snapshot: VERQUVO">Drug Trials Snapshot</a></td></tr></tbody></table></div><p><span style="font-size: x-small;">*The listed “FDA-approved use” on this website is for presentation purposes only. To see the FDA-approved conditions of use [e.g., indication(s), population(s), dosing regimen(s)] for each of these products, see the most recent FDA-approved Prescribing Information (click on the Drug Name) .</span></p>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-3434872007871507654.post-28461662606228112622013-02-15T20:34:00.002-08:002013-02-15T20:34:38.824-08:002013 FDA Drug Approval Decision Calendar<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"><u></u></span></b><br />
<b><span style="font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"><span style="color: black; font-size: large;">2013 FDA Drug Approval Decision Calendar</span></span></b><br />
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"><span style="color: blue;"><u>Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst -- FDA drug approval decisions and advisory panels.<br /><b>Johnson & Johnson</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/JNJ.html">JNJ</a><a class="arrow" href="http://www.thestreet.com/quote/JNJ.html"><span class="tickerChange" id="story_JNJ"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Canagliflozin for diabetes.<br /><b>FDA advisory panel:</b> Jan. 10<br /><b>Approval decision date:</b> March 29<br /><b>Theravance</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/THRX.html">THRX</a><a class="arrow" href="http://www.thestreet.com/quote/THRX.html"><span class="tickerChange" id="story_THRX"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Vibativ for hospital acquired pneumonia<br /><b>Approval decision date:</b> Jan. 11<b>Santarus</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/SNTS.html">SNTS</a><a class="arrow" href="http://www.thestreet.com/quote/SNTS.html"><span class="tickerChange" id="story_SNTS"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Uceris for ulcerative colitis<br /><b>Approval decision date:</b> Jan. 16<b>NuPathe</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/PATH.html">PATH</a><a class="arrow" href="http://www.thestreet.com/quote/PATH.html"><span class="tickerChange" id="story_PATH"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Zelrix for migraine<br /><b>Approval decision date:</b> Jan. 17, 2013<b>Impax Labs</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/IPXL.html">IPXL</a><a class="arrow" href="http://www.thestreet.com/quote/IPXL.html"><span class="tickerChange" id="story_IPXL"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> IPX066 for Parkinson's disease<br /><b>Approval decision date:</b> Jan. 21<b>Hyperion Therapeutics</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/HPTX.html">HPTX</a><a class="arrow" href="http://www.thestreet.com/quote/HPTX.html"><span class="tickerChange" id="story_HPTX"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Ravicti for urea cycle disorder<br /><b>Approval decision date:</b> Jan. 23<b>Sanofi</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/SNY.html">SNY</a><a class="arrow" href="http://www.thestreet.com/quote/SNY.html"><span class="tickerChange" id="story_SNY"><span class="tickerDown"><em>_</em></span></span></a>)</span> and <b>Isis Pharmaceuticals</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/ISIS.html">ISIS</a><a class="arrow" href="http://www.thestreet.com/quote/ISIS.html"><span class="tickerChange" id="story_ISIS"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Kynamro for dyslipidemia/hypercholesterolemia<br /><b>Approval decision date:</b> Jan. 29, 2013<b>Raptor Pharmaceutical</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/RPTP.html">RPTP</a><a class="arrow" href="http://www.thestreet.com/quote/RPTP.html"><span class="tickerChange" id="story_RPTP"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> RP103 for cystinosis<br /><b>Approval decision date:</b> Jan. 30, 2013<b>Hemispherx Biopharma</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/HEB.html">HEB</a><a class="arrow" href="http://www.thestreet.com/quote/HEB.html"><span class="tickerChange" id="story_HEB"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Ampligen for chronic fatigue syndrome<br /><b>Approval decision date:</b> Feb. 1, 2013<b>Celgene</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/CELG.html">CELG</a><a class="arrow" href="http://www.thestreet.com/quote/CELG.html"><span class="tickerChange" id="story_CELG"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Pomalidomide for multiple myeloma<br /><b>Approval decision date:</b> Feb. 8, 2013<b>Dynavax</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/DVAX.html">DVAX</a><a class="arrow" href="http://www.thestreet.com/quote/DVAX.html"><span class="tickerChange" id="story_DVAX"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Heplisav for hepatitis B prevention<br /><b>Approval decision date:</b> Feb. 22, 2013<b>Roche</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/RHHBY.html">RHHBY</a><a class="arrow" href="http://www.thestreet.com/quote/RHHBY.html"><span class="tickerChange" id="story_RHHBY"></span></a>)</span> and <b>Immunogen</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/IMGN.html">IMGN</a><a class="arrow" href="http://www.thestreet.com/quote/IMGN.html"><span class="tickerChange" id="story_IMGN"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> T-DM1 for breast cancer<br /><b>Approval decision date</b> Feb. 26<b>Zogenix</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/ZGNX.html">ZGNX</a><a class="arrow" href="http://www.thestreet.com/quote/ZGNX.html"><span class="tickerChange" id="story_ZGNX"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Zohydro for chronic pain<br /><b>Approval decision date:</b> March 1, 2013<b>Depomed</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/DEPO.html">DEPO</a><a class="arrow" href="http://www.thestreet.com/quote/DEPO.html"><span class="tickerChange" id="story_DEPO"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Serada for menopause<br /><b>FDA advisory panel:</b> March 4<br /><b>Approval decision date:</b> May 31<b>Bristol-Myers Squibb</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/BMY.html">BMY</a><a class="arrow" href="http://www.thestreet.com/quote/BMY.html"><span class="tickerChange" id="story_BMY"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Eliquis for blood clot prevention<br /><b>Approval decision date:</b> March 15<b>A.P. Pharma</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/APPA.html">APPA</a><a class="arrow" href="http://www.thestreet.com/quote/APPA.html"><span class="tickerChange" id="story_APPA"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> APF530 for chemotherapy induced nausea<br /><b>Approval decision date:</b> March 27<b>Biogen Idec</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/BIIB.html">BIIB</a><a class="arrow" href="http://www.thestreet.com/quote/BIIB.html"><span class="tickerChange" id="story_BIIB"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> BG-12 for multiple sclerosis<br /><b>Approval decision date:</b> March 28<b>MAP Pharma</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/MAPP.html">MAPP</a><a class="arrow" href="http://www.thestreet.com/quote/MAPP.html"><span class="tickerChange" id="story_MAPP"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Levadex for migraine<br /><b>Approval decision date:</b> April 15<b>Sucampo Pharmaceuticals</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/SCMP.html">SCMP</a><a class="arrow" href="http://www.thestreet.com/quote/SCMP.html"><span class="tickerChange" id="story_SCMP"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Amitzia for opioid-induced constipation<br /><b>Approval decision date:</b> April 26<b>Navidea Biopharmaceuticals</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/NAVB.html">NAVB</a><a class="arrow" href="http://www.thestreet.com/quote/NAVB.html"><span class="tickerChange" id="story_NAVB"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Lymphoseek, a radioactive tracing agent for lymph node mapping<br /><b>Approval decision date:</b> April 30<b>GlaxoSmithKline</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/GSK.html">GSK</a><a class="arrow" href="http://www.thestreet.com/quote/GSK.html"><span class="tickerChange" id="story_GSK"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Dabrefenib for melanoma<br /><b>FDA advisory panel:</b> June 3<b>Delcath Systems</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/DCTH.html">DCTH</a><a class="arrow" href="http://www.thestreet.com/quote/DCTH.html"><span class="tickerChange" id="story_DCTH"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> ChemoSat for liver metastases due to ocular melanoma<br /><b>Approval decision date:</b> June 14<b>AVEO Pharmaceuticals</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/AVEO.html">AVEO</a><a class="arrow" href="http://www.thestreet.com/quote/AVEO.html"><span class="tickerChange" id="story_AVEO"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Tivozanib for kidney cancer<br /><b>Approval decision date:</b> July 28Companies with drugs filed to FDA but no assigned approval decision dates:<b>Auxillium Pharmaceuticals</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/AUXL.html">AUXL</a><a class="arrow" href="http://www.thestreet.com/quote/AUXL.html"><span class="tickerChange" id="story_AUXL"><span class="tickerDown"><em>_</em></span></span></a>)</span>: Xiaflex for Peyronie's disease<br /><b>Bayer</b> and <b>Algeta</b>: Alpharadin for prostate cancer<br /><b>Antares Pharma</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/ATRS.html">ATRS</a><a class="arrow" href="http://www.thestreet.com/quote/ATRS.html"><span class="tickerChange" id="story_ATRS"><span class="tickerDown"><em>_</em></span></span></a>)</span>: Otrexup for rheumatoid arthritis<br />GlaxoSmithKline: Dolutegravir for HIVSources: Company reports, <i>TheStreet</i> research, <a href="http://www.biomedtracker.com/">BioMedTracker</a> --Written by Adam Feuerstein in Boston.</u></span></span></b><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"><span style="color: blue;"><u></u></span></span></b>Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-3434872007871507654.post-14919198259469800832011-12-16T16:47:00.001-08:002013-02-15T20:31:14.375-08:002013 FDA Expected Approvals!!<div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;">
<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"><u></u></span></b><br />
<b><span style="font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"><span style="color: black; font-size: large;">2013 FDA Drug Approval Decision Calendar</span></span></b><br />
<b><span style="font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"><br />
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"><span style="color: blue;"><u>Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst -- FDA drug approval decisions and advisory panels.<br />
<b>Johnson & Johnson</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/JNJ.html">JNJ</a><a class="arrow" href="http://www.thestreet.com/quote/JNJ.html"><span class="tickerChange" id="story_JNJ"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Canagliflozin for diabetes.<br /><b>FDA advisory panel:</b> Jan. 10<br /><b>Approval decision date:</b> March 29<br />
<b>Theravance</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/THRX.html">THRX</a><a class="arrow" href="http://www.thestreet.com/quote/THRX.html"><span class="tickerChange" id="story_THRX"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Vibativ for hospital acquired pneumonia<br /><b>Approval decision date:</b> Jan. 11<b>Santarus</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/SNTS.html">SNTS</a><a class="arrow" href="http://www.thestreet.com/quote/SNTS.html"><span class="tickerChange" id="story_SNTS"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Uceris for ulcerative colitis<br /><b>Approval decision date:</b> Jan. 16<b>NuPathe</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/PATH.html">PATH</a><a class="arrow" href="http://www.thestreet.com/quote/PATH.html"><span class="tickerChange" id="story_PATH"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Zelrix for migraine<br /><b>Approval decision date:</b> Jan. 17, 2013<b>Impax Labs</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/IPXL.html">IPXL</a><a class="arrow" href="http://www.thestreet.com/quote/IPXL.html"><span class="tickerChange" id="story_IPXL"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> IPX066 for Parkinson's disease<br /><b>Approval decision date:</b> Jan. 21<b>Hyperion Therapeutics</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/HPTX.html">HPTX</a><a class="arrow" href="http://www.thestreet.com/quote/HPTX.html"><span class="tickerChange" id="story_HPTX"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Ravicti for urea cycle disorder<br /><b>Approval decision date:</b> Jan. 23<b>Sanofi</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/SNY.html">SNY</a><a class="arrow" href="http://www.thestreet.com/quote/SNY.html"><span class="tickerChange" id="story_SNY"><span class="tickerDown"><em>_</em></span></span></a>)</span> and <b>Isis Pharmaceuticals</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/ISIS.html">ISIS</a><a class="arrow" href="http://www.thestreet.com/quote/ISIS.html"><span class="tickerChange" id="story_ISIS"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Kynamro for dyslipidemia/hypercholesterolemia<br /><b>Approval decision date:</b> Jan. 29, 2013<b>Raptor Pharmaceutical</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/RPTP.html">RPTP</a><a class="arrow" href="http://www.thestreet.com/quote/RPTP.html"><span class="tickerChange" id="story_RPTP"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> RP103 for cystinosis<br /><b>Approval decision date:</b> Jan. 30, 2013<b>Hemispherx Biopharma</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/HEB.html">HEB</a><a class="arrow" href="http://www.thestreet.com/quote/HEB.html"><span class="tickerChange" id="story_HEB"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Ampligen for chronic fatigue syndrome<br /><b>Approval decision date:</b> Feb. 1, 2013<b>Celgene</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/CELG.html">CELG</a><a class="arrow" href="http://www.thestreet.com/quote/CELG.html"><span class="tickerChange" id="story_CELG"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Pomalidomide for multiple myeloma<br /><b>Approval decision date:</b> Feb. 8, 2013<b>Dynavax</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/DVAX.html">DVAX</a><a class="arrow" href="http://www.thestreet.com/quote/DVAX.html"><span class="tickerChange" id="story_DVAX"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Heplisav for hepatitis B prevention<br /><b>Approval decision date:</b> Feb. 22, 2013<b>Roche</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/RHHBY.html">RHHBY</a><a class="arrow" href="http://www.thestreet.com/quote/RHHBY.html"><span class="tickerChange" id="story_RHHBY"></span></a>)</span> and <b>Immunogen</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/IMGN.html">IMGN</a><a class="arrow" href="http://www.thestreet.com/quote/IMGN.html"><span class="tickerChange" id="story_IMGN"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> T-DM1 for breast cancer<br /><b>Approval decision date</b> Feb. 26<b>Zogenix</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/ZGNX.html">ZGNX</a><a class="arrow" href="http://www.thestreet.com/quote/ZGNX.html"><span class="tickerChange" id="story_ZGNX"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Zohydro for chronic pain<br /><b>Approval decision date:</b> March 1, 2013<b>Depomed</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/DEPO.html">DEPO</a><a class="arrow" href="http://www.thestreet.com/quote/DEPO.html"><span class="tickerChange" id="story_DEPO"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Serada for menopause<br /><b>FDA advisory panel:</b> March 4<br /><b>Approval decision date:</b> May 31<b>Bristol-Myers Squibb</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/BMY.html">BMY</a><a class="arrow" href="http://www.thestreet.com/quote/BMY.html"><span class="tickerChange" id="story_BMY"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Eliquis for blood clot prevention<br /><b>Approval decision date:</b> March 15<b>A.P. Pharma</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/APPA.html">APPA</a><a class="arrow" href="http://www.thestreet.com/quote/APPA.html"><span class="tickerChange" id="story_APPA"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> APF530 for chemotherapy induced nausea<br /><b>Approval decision date:</b> March 27<b>Biogen Idec</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/BIIB.html">BIIB</a><a class="arrow" href="http://www.thestreet.com/quote/BIIB.html"><span class="tickerChange" id="story_BIIB"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> BG-12 for multiple sclerosis<br /><b>Approval decision date:</b> March 28<b>MAP Pharma</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/MAPP.html">MAPP</a><a class="arrow" href="http://www.thestreet.com/quote/MAPP.html"><span class="tickerChange" id="story_MAPP"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Levadex for migraine<br /><b>Approval decision date:</b> April 15<b>Sucampo Pharmaceuticals</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/SCMP.html">SCMP</a><a class="arrow" href="http://www.thestreet.com/quote/SCMP.html"><span class="tickerChange" id="story_SCMP"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Amitzia for opioid-induced constipation<br /><b>Approval decision date:</b> April 26<b>Navidea Biopharmaceuticals</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/NAVB.html">NAVB</a><a class="arrow" href="http://www.thestreet.com/quote/NAVB.html"><span class="tickerChange" id="story_NAVB"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Lymphoseek, a radioactive tracing agent for lymph node mapping<br /><b>Approval decision date:</b> April 30<b>GlaxoSmithKline</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/GSK.html">GSK</a><a class="arrow" href="http://www.thestreet.com/quote/GSK.html"><span class="tickerChange" id="story_GSK"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Dabrefenib for melanoma<br /><b>FDA advisory panel:</b> June 3<b>Delcath Systems</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/DCTH.html">DCTH</a><a class="arrow" href="http://www.thestreet.com/quote/DCTH.html"><span class="tickerChange" id="story_DCTH"><span class="tickerUp"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> ChemoSat for liver metastases due to ocular melanoma<br /><b>Approval decision date:</b> June 14<b>AVEO Pharmaceuticals</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/AVEO.html">AVEO</a><a class="arrow" href="http://www.thestreet.com/quote/AVEO.html"><span class="tickerChange" id="story_AVEO"><span class="tickerDown"><em>_</em></span></span></a>)</span><br /><b>Drug/indication:</b> Tivozanib for kidney cancer<br /><b>Approval decision date:</b> July 28Companies with drugs filed to FDA but no assigned approval decision dates:<b>Auxillium Pharmaceuticals</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/AUXL.html">AUXL</a><a class="arrow" href="http://www.thestreet.com/quote/AUXL.html"><span class="tickerChange" id="story_AUXL"><span class="tickerDown"><em>_</em></span></span></a>)</span>: Xiaflex for Peyronie's disease<br /><b>Bayer</b> and <b>Algeta</b>: Alpharadin for prostate cancer<br /><b>Antares Pharma</b><span class="TICKERFLAT">(<a href="http://www.thestreet.com/quote/ATRS.html">ATRS</a><a class="arrow" href="http://www.thestreet.com/quote/ATRS.html"><span class="tickerChange" id="story_ATRS"><span class="tickerDown"><em>_</em></span></span></a>)</span>: Otrexup for rheumatoid arthritis<br />GlaxoSmithKline: Dolutegravir for HIVSources: Company reports, <i>TheStreet</i> research, <a href="http://www.biomedtracker.com/">BioMedTracker</a> --Written by Adam Feuerstein in Boston.<br /></u></span></span></b><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"><span style="color: blue;"><u></u></span></span></b><br />
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"><span style="color: blue;"><u>2012 FDA Expected Approvals!!</u></span></span></b><br />
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Affymax</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/AFFY.html"><span style="color: blue;">AFFY</span></a><a href="http://www.thestreet.com/quote/AFFY.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b>peginesatide for anemia in kidney dialysis patients. <br />
<b>FDA advisory panel:</b> Dec. 7, 2011 <br />
<b>Approval decision date:</b>March 27, 2012 <br />
Peginesatide, injected once monthly, aims to compete against <b>Amgen's</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/AMGN.html"><span style="color: blue;">AMGN</span></a><a href="http://www.thestreet.com/quote/AMGN.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> Epogen ($2.5 billion in 2010 sales) as a treatment for anemia in patients with chronic kidney disease, although peginesatide use would be limited to sicker kidney dialysis patients only. Amgen recently signed long-term Epogen supply contracts with the two largest kidney dialysis clinics in the <a href="http://www.thestreet.com/story/11324723/1/22-hot-drugs-facing-fda-approval-in-2012.html"><span style="color: darkgreen; mso-bidi-font-size: 11.0pt;">U.S.</span></a> </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Pfizer</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/PFE.html"><span style="color: blue;">PFE</span></a><a href="http://www.thestreet.com/quote/PFE.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b>Inlyta (axitinib) for kidney cancer <br />
<b>FDA advisory panel:</b> Dec. 7, 2011 <br />
<b>Approval decision date:</b> Feb-April 2012 </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Alexza Pharmaceuticals</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/ALXA.html"><span style="color: blue;">ALXA</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b>Adasuve for agitation related to schizophrenia <br />
<b>FDA advisory panel:</b> Dec. 12, 2011 <br />
<b>Approval decision date:</b> Feb. 4, 2012 <br />
Adasuve uses Alexza's proprietary Staccato inhaler system to deliver the anti-agitation medicine loxapine directly into the lungs where it gets into the bloodstream and begins to work quickly. The FDA advisory panel is expected to focus much of its attention on the potential side effects and safety issues related to delivering Adasuve into patients' lungs. </span></div>
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<span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">FDA initially rejected Adasuve in October 2010 due to concerns over lung safety. Alexza resubmitted the drug to FDA last August. </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Vivus</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/VVUS.html"><span style="color: blue;">VVUS</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">, <b>Arena Pharmaceuticals</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/ARNA.html"><span style="color: blue;">ARNA</span></a><a href="http://www.thestreet.com/quote/ARNA.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> and <b>Orexigen Therapeutics</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/OREX.html"><span style="color: blue;">OREX</span></a><a href="http://www.thestreet.com/quote/OREX.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drugs/indication:</b> Qnexa, lorcaserin and Contrave for obesity. <br />
<b>FDA advisory panel:</b> First quarter 2012 (exact date not yet disclosed.) <br />
FDA held advisory panels to review all three of these controversial weight-loss drugs in 2010. FDA subsequently rejected all three drugs. In 2012, Vivus and its obesity drug competitors are back for another shot, and FDA will once again bring together a group of outside experts to weigh the pros and cons of treating obesity with a pill.</span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt;">Biogen Idec</span></b><span class="tickerflat"><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt;">(<a href="http://www.thestreet.com/quote/BIIB.html"><span style="color: blue;">BIIB</span></a><a href="http://www.thestreet.com/quote/BIIB.html"><span style="color: white; text-decoration: none; text-underline: none;"><span id="story_BIIB">_</span></span></a>)</span></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt;"> and <b>Elan</b> <span class="tickerflat">(<a href="http://www.thestreet.com/quote/ELN.html"><span style="color: blue;">ELN</span></a><a href="http://www.thestreet.com/quote/ELN.html"><span style="color: white; text-decoration: none; text-underline: none;"><span id="story_ELN">_</span></span></a>)</span> <br />
<b>Drug/indication:</b>Update to the Tysabri prescribing label <br />
<b>Approval decision date:</b> Jan. 20, 2012 <br />
The Tysabri label update will include information about the anti-JC virus antibody status as a factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML). Doctors can use to test to determine which multiple sclerosis patients are at low or high risk for PML, a serious, potentially fatal brain infection caused by Tysabri.<b> </b></span><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Columbia Labs</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/CBRX.html"><span style="color: blue;">CBRX</span></a><a href="http://www.thestreet.com/quote/CBRX.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> and <b>Watson Pharmaceuticals</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/WPI.html"><span style="color: blue;">WPI</span></a><a href="http://www.thestreet.com/quote/WPI.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b>progesterone vaginal gel for risk reduction of preterm birth. <br />
<b>FDA advisory panel:</b> Jan. 20, 2012 <br />
<b>Approval decision date:</b>Feb. 26, 2012 </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Amylin Pharmaceuticals</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/AMLN.html"><span style="color: blue;">AMLN</span></a><a href="http://www.thestreet.com/quote/AMLN.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Bydureon for diabetes <br />
<b>Approval decision date:</b> Jan. 27, 2012 <br />
This is the second shot at approval for Bydureon, a once-weekly injectable medicine for the treatment of Type 2 diabetes. Amylin recently split with its long-time marketing partner <b>Eli Lilly</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/LLY.html"><span style="color: blue;">LLY</span></a><a href="http://www.thestreet.com/quote/LLY.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">. <b>Alkermes</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/ALKS.html"><span style="color: blue;">ALKS</span></a><a href="http://www.thestreet.com/quote/ALKS.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> retains its royalty split on Bydureon sales. </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Bristol-Myers Squibb</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/BMY.html"><span style="color: blue;">BMY</span></a><a href="http://www.thestreet.com/quote/BMY.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> dapagliflozin for diabetes <br />
<b>Approval decision date:</b> Jan. 27, 2012 </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Pfizer</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/PFE.html"><span style="color: blue;">PFE</span></a><a href="http://www.thestreet.com/quote/PFE.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> and <b>Protalix Biotherapeutics</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/PLX.html"><span style="color: blue;">PLX</span></a><a href="http://www.thestreet.com/quote/PLX.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Uplyso for Gaucher's disease. <br />
<b>Approval decision date:</b> Feb. 1, 2012 <br />
FDA has twice-rejected Uplyso due to manufacturing and quality control issues. If approved this time around, Uplyso will compete against <b>Sanofi/Genzyme's</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/SNY.html"><span style="color: blue;">SNY</span></a><a href="http://www.thestreet.com/quote/SNY.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> Cerezyme and <b>Shire's</b> Vpriv. </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Teva</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/TEVA.html"><span style="color: blue;">TEVA</span></a><a href="http://www.thestreet.com/quote/TEVA.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> and <b>BioSante Pharmaceuticals</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/BPAX.html"><span style="color: blue;">BPAX</span></a><a href="http://www.thestreet.com/quote/BPAX.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Bio-T-Gel for hypogonadism <br />
<b>Approval decision date:</b> Feb. 14, 2012 <br />
Bio-T-Gel is a once-daily gel used to treat low testosterone in men. </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Corcept Pharmaceuticals</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/CORT.html"><span style="color: blue;">CORT</span></a><a href="http://www.thestreet.com/quote/CORT.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Corlux for Cushing's Syndrome. <br />
<b>Approval decision date:</b> Feb. 17, 2012 <br />
FDA will not convene an advisory panel to review Corlux. </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Discovery Labs</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/DSCO.html"><span style="color: blue;">DSCO</span></a><a href="http://www.thestreet.com/quote/DSCO.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Surfaxin for respiratory distress syndrome in premature infants. <br />
<b>Approval decision date:</b> March 6, 2012 <br />
This is Discovery's fifth attempt at convincing FDA to approve Surfaxin. </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Roche</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/RHHBY.html"><span style="color: blue;">RHHBY</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> and <b>Curis</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/CRIS.html"><span style="color: blue;">CRIS</span></a><a href="http://www.thestreet.com/quote/CRIS.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Vismodegib for advanced basal cell carcinoma. <br />
<b>Approval decision date:</b> March 8, 2012. </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">MAP Pharmaceuticals</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/MAPP.html"><span style="color: blue;">MAPP</span></a><a href="http://www.thestreet.com/quote/MAPP.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Levadex for migraines <br />
<b>Approval decision date:</b> March 26, 2012 <br />
Levadex is an inhaled migraine drug. FDA has not yet announced whether it intends to hold an advisory panel to review Levadex. </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Chelsea Therapeutics</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/CHTP.html"><span style="color: blue;">CHTP</span></a><a href="http://www.thestreet.com/quote/CHTP.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Northera for orthostatic hypotension <br />
<b>Approval decision date:</b> March 28, 2012 </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Pfizer</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/PFE.html"><span style="color: blue;">PFE</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> and <b>Bristol-Myers Squibb</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/BMY.html"><span style="color: blue;">BMY</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Eliquis for prevention of stroke and blood clots in patients with atrial fibrilation. <br />
<b>Approval decision date:</b> March 28, 2012 </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Onyx Pharmaceuticals</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/ONXX.html"><span style="color: blue;">ONXX</span></a><a href="http://www.thestreet.com/quote/ONXX.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Carfilzomib for multiple myeloma <br />
<b>Approval decision date:</b> March 28, 2012 (estimated, not confirmed, based on Sept. 28, 2011 filing date. <br />
FDA accepted the carfilzomib filing on Nov. 28 but has not yet set a specific approval decision date. I'm assuming a six-month priority review because carfilzomib is a cancer drug. </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Vivus</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/VVUS.html"><span style="color: blue;">VVUS</span></a><a href="http://www.thestreet.com/quote/VVUS.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Qnexa for obesity <br />
<b>Approval decision date:</b> April 17, 2012 <br />
FDA rejected Qnexa initially in 2010 due to safety concerns. </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Vertex Pharmaceuticals</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/VRTX.html"><span style="color: blue;">VRTX</span></a><a href="http://www.thestreet.com/quote/VRTX.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Kalydeco for cystic fibrosis <br />
<b>Approval decision date:</b> April 19, 2012 <br />
Kalydeco is the first drug to treat the underlying cause of cystic fibrosis in patients with a specific genetic defect. </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Cell Therapeutics</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/CTIC.html"><span style="color: blue;">CTIC</span></a><a href="http://www.thestreet.com/quote/CTIC.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> pixantrone for non-Hodgkin's lymphoma <br />
<b>Approval decision date:</b> April 2012 (Specific date unknown.) <br />
Cell Therapeutics appealed the FDA's 2009 decision to reject pixantrone, setting up the drug's second chance at U.S. approval. </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Amgen</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/AMGN.html"><span style="color: blue;">AMGN</span></a><a href="http://www.thestreet.com/quote/AMGN.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Xgeva for prevention of bone metastases from prostate cancer. <br />
<b>Approval decision date:</b> April 26, 2012 </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">VVUS</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/VVUS.html"><span style="color: blue;">VVUS</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Avanafil for erectile dysfunction. <br />
<b>Approval decision date:</b> April 29, 2012 </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Merck</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/MRK.html"><span style="color: blue;">MRK</span></a><a href="http://www.thestreet.com/quote/MRK.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> and <b>Ariad Pharmaceuticals</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/ARIA.html"><span style="color: blue;">ARIA</span></a><a href="http://www.thestreet.com/quote/ARIA.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> ridaforolimus for sarcoma. <br />
<b>Approval decision date:</b> June 5, 2012 </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Ironwood Pharmaceuticals</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/IRWD.html"><span style="color: blue;">IRWD</span></a><a href="http://www.thestreet.com/quote/IRWD.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> linaclotide for irritable bowel syndrome. <br />
<b>Approval decision date:</b> June 8, 2012 </span></div>
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<b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Amarin</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/AMRN.html"><span style="color: blue;">AMRN</span></a><a href="http://www.thestreet.com/quote/AMRN.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> AMR101 for dyslipidemia. <br />
<b>Approval decision date:</b> July 26, 2012 </span></div>
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<span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Sources: Company reports, TheStreet research, <a href="http://www.biomedtracker.com/"><span style="mso-bidi-font-size: 11.0pt;"><span style="color: blue;">BioMedTracker.com</span></span></a> </span></div>
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<span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">--Written by Adam Feuerstein in Boston</span></div>
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Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-3434872007871507654.post-50833539706066792042011-12-16T16:43:00.000-08:002011-12-16T16:43:49.042-08:002012 FDA Expected Approvals!!<div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; mso-fareast-font-family: "Times New Roman";"><span style="color: blue;">2012 FDA Approvals!!</span></span></b></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; mso-fareast-font-family: "Times New Roman";"><span style="color: blue;">Please help keeping this post active by clicking on some ads in this page. Thanks and good luck!</span></span></b></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><br />
</div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Affymax</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/AFFY.html"><span style="color: blue;">AFFY</span></a><a href="http://www.thestreet.com/quote/AFFY.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b>peginesatide for anemia in kidney dialysis patients. <br />
<b>FDA advisory panel:</b> Dec. 7, 2011 <br />
<b>Approval decision date:</b>March 27, 2012 <br />
Peginesatide, injected once monthly, aims to compete against <b>Amgen's</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/AMGN.html"><span style="color: blue;">AMGN</span></a><a href="http://www.thestreet.com/quote/AMGN.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> Epogen ($2.5 billion in 2010 sales) as a treatment for anemia in patients with chronic kidney disease, although peginesatide use would be limited to sicker kidney dialysis patients only. Amgen recently signed long-term Epogen supply contracts with the two largest kidney dialysis clinics in the <a href="http://www.thestreet.com/story/11324723/1/22-hot-drugs-facing-fda-approval-in-2012.html"><span style="color: darkgreen; mso-bidi-font-size: 11.0pt;">U.S.</span></a> </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Pfizer</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/PFE.html"><span style="color: blue;">PFE</span></a><a href="http://www.thestreet.com/quote/PFE.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b>Inlyta (axitinib) for kidney cancer <br />
<b>FDA advisory panel:</b> Dec. 7, 2011 <br />
<b>Approval decision date:</b> Feb-April 2012 </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Alexza Pharmaceuticals</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/ALXA.html"><span style="color: blue;">ALXA</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b>Adasuve for agitation related to schizophrenia <br />
<b>FDA advisory panel:</b> Dec. 12, 2011 <br />
<b>Approval decision date:</b> Feb. 4, 2012 <br />
Adasuve uses Alexza's proprietary Staccato inhaler system to deliver the anti-agitation medicine loxapine directly into the lungs where it gets into the bloodstream and begins to work quickly. The FDA advisory panel is expected to focus much of its attention on the potential side effects and safety issues related to delivering Adasuve into patients' lungs. </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 15pt;"><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">FDA initially rejected Adasuve in October 2010 due to concerns over lung safety. Alexza resubmitted the drug to FDA last August. </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 5pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Vivus</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/VVUS.html"><span style="color: blue;">VVUS</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">, <b>Arena Pharmaceuticals</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/ARNA.html"><span style="color: blue;">ARNA</span></a><a href="http://www.thestreet.com/quote/ARNA.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> and <b>Orexigen Therapeutics</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/OREX.html"><span style="color: blue;">OREX</span></a><a href="http://www.thestreet.com/quote/OREX.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drugs/indication:</b> Qnexa, lorcaserin and Contrave for obesity. <br />
<b>FDA advisory panel:</b> First quarter 2012 (exact date not yet disclosed.) <br />
FDA held advisory panels to review all three of these controversial weight-loss drugs in 2010. FDA subsequently rejected all three drugs. In 2012, Vivus and its obesity drug competitors are back for another shot, and FDA will once again bring together a group of outside experts to weigh the pros and cons of treating obesity with a pill.</span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 10pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt;">Biogen Idec</span></b><span class="tickerflat"><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt;">(<a href="http://www.thestreet.com/quote/BIIB.html"><span style="color: blue;">BIIB</span></a><a href="http://www.thestreet.com/quote/BIIB.html"><span style="color: white; text-decoration: none; text-underline: none;"><span id="story_BIIB">_</span></span></a>)</span></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt;"> and <b>Elan</b> <span class="tickerflat">(<a href="http://www.thestreet.com/quote/ELN.html"><span style="color: blue;">ELN</span></a><a href="http://www.thestreet.com/quote/ELN.html"><span style="color: white; text-decoration: none; text-underline: none;"><span id="story_ELN">_</span></span></a>)</span> <br />
<b>Drug/indication:</b>Update to the Tysabri prescribing label <br />
<b>Approval decision date:</b> Jan. 20, 2012 <br />
The Tysabri label update will include information about the anti-JC virus antibody status as a factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML). Doctors can use to test to determine which multiple sclerosis patients are at low or high risk for PML, a serious, potentially fatal brain infection caused by Tysabri.<b> </b></span><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Columbia Labs</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/CBRX.html"><span style="color: blue;">CBRX</span></a><a href="http://www.thestreet.com/quote/CBRX.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> and <b>Watson Pharmaceuticals</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/WPI.html"><span style="color: blue;">WPI</span></a><a href="http://www.thestreet.com/quote/WPI.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b>progesterone vaginal gel for risk reduction of preterm birth. <br />
<b>FDA advisory panel:</b> Jan. 20, 2012 <br />
<b>Approval decision date:</b>Feb. 26, 2012 </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Amylin Pharmaceuticals</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/AMLN.html"><span style="color: blue;">AMLN</span></a><a href="http://www.thestreet.com/quote/AMLN.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Bydureon for diabetes <br />
<b>Approval decision date:</b> Jan. 27, 2012 <br />
This is the second shot at approval for Bydureon, a once-weekly injectable medicine for the treatment of Type 2 diabetes. Amylin recently split with its long-time marketing partner <b>Eli Lilly</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/LLY.html"><span style="color: blue;">LLY</span></a><a href="http://www.thestreet.com/quote/LLY.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">. <b>Alkermes</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/ALKS.html"><span style="color: blue;">ALKS</span></a><a href="http://www.thestreet.com/quote/ALKS.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> retains its royalty split on Bydureon sales. </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Bristol-Myers Squibb</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/BMY.html"><span style="color: blue;">BMY</span></a><a href="http://www.thestreet.com/quote/BMY.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> dapagliflozin for diabetes <br />
<b>Approval decision date:</b> Jan. 27, 2012 </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Pfizer</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/PFE.html"><span style="color: blue;">PFE</span></a><a href="http://www.thestreet.com/quote/PFE.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> and <b>Protalix Biotherapeutics</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/PLX.html"><span style="color: blue;">PLX</span></a><a href="http://www.thestreet.com/quote/PLX.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Uplyso for Gaucher's disease. <br />
<b>Approval decision date:</b> Feb. 1, 2012 <br />
FDA has twice-rejected Uplyso due to manufacturing and quality control issues. If approved this time around, Uplyso will compete against <b>Sanofi/Genzyme's</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/SNY.html"><span style="color: blue;">SNY</span></a><a href="http://www.thestreet.com/quote/SNY.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> Cerezyme and <b>Shire's</b> Vpriv. </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Teva</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/TEVA.html"><span style="color: blue;">TEVA</span></a><a href="http://www.thestreet.com/quote/TEVA.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> and <b>BioSante Pharmaceuticals</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/BPAX.html"><span style="color: blue;">BPAX</span></a><a href="http://www.thestreet.com/quote/BPAX.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Bio-T-Gel for hypogonadism <br />
<b>Approval decision date:</b> Feb. 14, 2012 <br />
Bio-T-Gel is a once-daily gel used to treat low testosterone in men. </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Corcept Pharmaceuticals</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/CORT.html"><span style="color: blue;">CORT</span></a><a href="http://www.thestreet.com/quote/CORT.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Corlux for Cushing's Syndrome. <br />
<b>Approval decision date:</b> Feb. 17, 2012 <br />
FDA will not convene an advisory panel to review Corlux. </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Discovery Labs</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/DSCO.html"><span style="color: blue;">DSCO</span></a><a href="http://www.thestreet.com/quote/DSCO.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Surfaxin for respiratory distress syndrome in premature infants. <br />
<b>Approval decision date:</b> March 6, 2012 <br />
This is Discovery's fifth attempt at convincing FDA to approve Surfaxin. </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Roche</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/RHHBY.html"><span style="color: blue;">RHHBY</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> and <b>Curis</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/CRIS.html"><span style="color: blue;">CRIS</span></a><a href="http://www.thestreet.com/quote/CRIS.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Vismodegib for advanced basal cell carcinoma. <br />
<b>Approval decision date:</b> March 8, 2012. </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">MAP Pharmaceuticals</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/MAPP.html"><span style="color: blue;">MAPP</span></a><a href="http://www.thestreet.com/quote/MAPP.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Levadex for migraines <br />
<b>Approval decision date:</b> March 26, 2012 <br />
Levadex is an inhaled migraine drug. FDA has not yet announced whether it intends to hold an advisory panel to review Levadex. </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Chelsea Therapeutics</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/CHTP.html"><span style="color: blue;">CHTP</span></a><a href="http://www.thestreet.com/quote/CHTP.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Northera for orthostatic hypotension <br />
<b>Approval decision date:</b> March 28, 2012 </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Pfizer</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/PFE.html"><span style="color: blue;">PFE</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> and <b>Bristol-Myers Squibb</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/BMY.html"><span style="color: blue;">BMY</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Eliquis for prevention of stroke and blood clots in patients with atrial fibrilation. <br />
<b>Approval decision date:</b> March 28, 2012 </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Onyx Pharmaceuticals</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/ONXX.html"><span style="color: blue;">ONXX</span></a><a href="http://www.thestreet.com/quote/ONXX.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Carfilzomib for multiple myeloma <br />
<b>Approval decision date:</b> March 28, 2012 (estimated, not confirmed, based on Sept. 28, 2011 filing date. <br />
FDA accepted the carfilzomib filing on Nov. 28 but has not yet set a specific approval decision date. I'm assuming a six-month priority review because carfilzomib is a cancer drug. </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Vivus</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/VVUS.html"><span style="color: blue;">VVUS</span></a><a href="http://www.thestreet.com/quote/VVUS.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Qnexa for obesity <br />
<b>Approval decision date:</b> April 17, 2012 <br />
FDA rejected Qnexa initially in 2010 due to safety concerns. </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Vertex Pharmaceuticals</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/VRTX.html"><span style="color: blue;">VRTX</span></a><a href="http://www.thestreet.com/quote/VRTX.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Kalydeco for cystic fibrosis <br />
<b>Approval decision date:</b> April 19, 2012 <br />
Kalydeco is the first drug to treat the underlying cause of cystic fibrosis in patients with a specific genetic defect. </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Cell Therapeutics</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/CTIC.html"><span style="color: blue;">CTIC</span></a><a href="http://www.thestreet.com/quote/CTIC.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> pixantrone for non-Hodgkin's lymphoma <br />
<b>Approval decision date:</b> April 2012 (Specific date unknown.) <br />
Cell Therapeutics appealed the FDA's 2009 decision to reject pixantrone, setting up the drug's second chance at U.S. approval. </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Amgen</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/AMGN.html"><span style="color: blue;">AMGN</span></a><a href="http://www.thestreet.com/quote/AMGN.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Xgeva for prevention of bone metastases from prostate cancer. <br />
<b>Approval decision date:</b> April 26, 2012 </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">VVUS</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/VVUS.html"><span style="color: blue;">VVUS</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> Avanafil for erectile dysfunction. <br />
<b>Approval decision date:</b> April 29, 2012 </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Merck</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/MRK.html"><span style="color: blue;">MRK</span></a><a href="http://www.thestreet.com/quote/MRK.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> and <b>Ariad Pharmaceuticals</b></span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/ARIA.html"><span style="color: blue;">ARIA</span></a><a href="http://www.thestreet.com/quote/ARIA.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> ridaforolimus for sarcoma. <br />
<b>Approval decision date:</b> June 5, 2012 </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 0pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Ironwood Pharmaceuticals</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/IRWD.html"><span style="color: blue;">IRWD</span></a><a href="http://www.thestreet.com/quote/IRWD.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> linaclotide for irritable bowel syndrome. <br />
<b>Approval decision date:</b> June 8, 2012 </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 5pt;"><b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Amarin</span></b><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-bidi-font-size: 11.0pt; mso-fareast-font-family: "Times New Roman";">(<a href="http://www.thestreet.com/quote/AMRN.html"><span style="color: blue;">AMRN</span></a><a href="http://www.thestreet.com/quote/AMRN.html"><span style="color: white; mso-bidi-font-size: 10.5pt; text-decoration: none; text-underline: none;">_</span></a>)</span><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";"> <br />
<b>Drug/indication:</b> AMR101 for dyslipidemia. <br />
<b>Approval decision date:</b> July 26, 2012 </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 15pt;"><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Sources: Company reports, TheStreet research, <a href="http://www.biomedtracker.com/"><span style="mso-bidi-font-size: 11.0pt;"><span style="color: blue;">BioMedTracker.com</span></span></a> </span></div><div class="MsoNormal" style="line-height: 15pt; margin: 0in 0in 15pt;"><span style="font-family: "Arial", "sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">--Written by Adam Feuerstein in Boston</span></div><div class="MsoNormal" style="margin: 0in 0in 10pt;"><br />
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