2013 FDA Drug Approval Decision Calendar


2013 FDA Drug Approval Decision Calendar

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Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst -- FDA drug approval decisions and advisory panels.
Johnson & Johnson(JNJ_)
Drug/indication: Canagliflozin for diabetes.
FDA advisory panel: Jan. 10
Approval decision date: March 29
Theravance(THRX_)
Drug/indication: Vibativ for hospital acquired pneumonia
Approval decision date: Jan. 11Santarus(SNTS_)
Drug/indication: Uceris for ulcerative colitis
Approval decision date: Jan. 16NuPathe(PATH_)
Drug/indication: Zelrix for migraine
Approval decision date: Jan. 17, 2013Impax Labs(IPXL_)
Drug/indication: IPX066 for Parkinson's disease
Approval decision date: Jan. 21Hyperion Therapeutics(HPTX_)
Drug/indication: Ravicti for urea cycle disorder
Approval decision date: Jan. 23Sanofi(SNY_) and Isis Pharmaceuticals(ISIS_)
Drug/indication: Kynamro for dyslipidemia/hypercholesterolemia
Approval decision date: Jan. 29, 2013Raptor Pharmaceutical(RPTP_)
Drug/indication: RP103 for cystinosis
Approval decision date: Jan. 30, 2013Hemispherx Biopharma(HEB_)
Drug/indication: Ampligen for chronic fatigue syndrome
Approval decision date: Feb. 1, 2013Celgene(CELG_)
Drug/indication: Pomalidomide for multiple myeloma
Approval decision date: Feb. 8, 2013Dynavax(DVAX_)
Drug/indication: Heplisav for hepatitis B prevention
Approval decision date: Feb. 22, 2013Roche(RHHBY) and Immunogen(IMGN_)
Drug/indication: T-DM1 for breast cancer
Approval decision date Feb. 26Zogenix(ZGNX_)
Drug/indication: Zohydro for chronic pain
Approval decision date: March 1, 2013Depomed(DEPO_)
Drug/indication: Serada for menopause
FDA advisory panel: March 4
Approval decision date: May 31Bristol-Myers Squibb(BMY_)
Drug/indication: Eliquis for blood clot prevention
Approval decision date: March 15A.P. Pharma(APPA_)
Drug/indication: APF530 for chemotherapy induced nausea
Approval decision date: March 27Biogen Idec(BIIB_)
Drug/indication: BG-12 for multiple sclerosis
Approval decision date: March 28MAP Pharma(MAPP_)
Drug/indication: Levadex for migraine
Approval decision date: April 15Sucampo Pharmaceuticals(SCMP_)
Drug/indication: Amitzia for opioid-induced constipation
Approval decision date: April 26Navidea Biopharmaceuticals(NAVB_)
Drug/indication: Lymphoseek, a radioactive tracing agent for lymph node mapping
Approval decision date: April 30GlaxoSmithKline(GSK_)
Drug/indication: Dabrefenib for melanoma
FDA advisory panel: June 3Delcath Systems(DCTH_)
Drug/indication: ChemoSat for liver metastases due to ocular melanoma
Approval decision date: June 14AVEO Pharmaceuticals(AVEO_)
Drug/indication: Tivozanib for kidney cancer
Approval decision date: July 28Companies with drugs filed to FDA but no assigned approval decision dates:Auxillium Pharmaceuticals(AUXL_): Xiaflex for Peyronie's disease
Bayer and Algeta: Alpharadin for prostate cancer
Antares Pharma(ATRS_): Otrexup for rheumatoid arthritis
GlaxoSmithKline: Dolutegravir for HIVSources: Company reports, TheStreet research, BioMedTracker --Written by Adam Feuerstein in Boston.

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