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FDA Drug Approvals for 2021

 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. 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. Each year, CDER approves a wide range of new drugs and biological products: 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
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2013 FDA Drug Approval Decision Calendar

2013 FDA Drug Approval Decision Calendar Please help keeping this post updated by clicking on some ads... 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. 11 Santarus ( SNTS _ ) Drug/indication: Uceris for ulcerative colitis Approval decision date: Jan. 16 NuPathe ( PATH _ ) Drug/indication: Zelrix for migraine Approval decision date: Jan. 17, 2013 Impax Labs ( IPXL _ ) Drug/indication: IPX066 for Parkinson's disease Approval decision date: Jan. 21 Hyperion Therapeutics ( HPTX _ ) Drug/indication: Ravicti for urea cycle disorder Approval decision date: Jan. 23 Sanofi ( SNY _ ) and Isis Pharmaceuticals ( ISIS _ ) Drug
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2013 FDA Expected Approvals!!

2013 FDA Drug Approval Decision Calendar Please help keeping this post updated by clicking on some ads... 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. 11 Santarus ( SNTS _ ) Drug/indication: Uceris for ulcerative colitis Approval decision date: Jan. 16 NuPathe ( PATH _ ) Drug/indication: Zelrix for migraine Approval decision date: Jan. 17, 2013 Impax Labs ( IPXL _ ) Drug/indication: IPX066 for Parkinson's disease Approval decision date: Jan. 21 Hyperion Therapeutics ( HPTX _ ) Drug/indication: Ravicti for urea cycle disorder Approval decision date: Jan. 23 Sanofi ( SNY _ ) and Isis Pharmaceuticals ( ISIS _ )
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2012 FDA Expected Approvals!!

2012 FDA Approvals!! Please help keeping this post active by clicking on some ads in this page. Thanks and good luck! Affymax ( AFFY _ ) Drug/indication: peginesatide for anemia in kidney dialysis patients. FDA advisory panel: Dec. 7, 2011 Approval decision date: March 27, 2012 Peginesatide, injected once monthly, aims to compete against Amgen's ( AMGN _ ) 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 U.S. Pfizer ( PFE _ ) Drug/indication: Inlyta (axitinib) for kidney cancer FDA advisory panel: Dec. 7, 2011 Approval decision date: Feb-April 2012 Alexza Pharmaceuticals ( ALXA ) Drug/indication: Adasuve for agitation related to schizophrenia FDA advisory panel: Dec. 12, 2011 Approval decision date: Feb. 4, 2012 Adasuv
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