FDA Calendar


DateCompany NameTickerDrugEventOutcomeDetails
01/09/2015Impax Laboratories Inc IPXL RYTARY (NDA)FDA decision on RYTARY for the treatment of idiopathic Parkinson's disease
-News
12/30/2014POZEN Inc. POZN PA8140/PA32540 (NDA resubmission)FDA decision on PA8140/PA32540 secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
-News
12/30/2014Vertex Pharmaceuticals Inc. VRTX KALYDECO (sNDA)FDA decision on KALYDECO for use in people with cystic fibrosis ages 6 and older who have R117H mutation
12/23/2014Biocryst Pharmaceuticals Inc BCRX Intravenous (i.v.) Peramivir (NDA)FDA decision on intravenous Peramivir for influenza
12/21/2014Cubist Pharmaceuticals Inc CBST Ceftolozane/Tazobactam (NDA) FDA decision on Ceftolozane/Tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections
12/05/2014Incyte Corporation INCY Ruxolitinib (sNDA)FDA decision on Ruxolitinib as a potential treatment in the addnl. indication of polycythemia vera patients who have had an inadequate response to or are intolerant of hydroxyurea
-Approved in Other Countries

11/26/2014Avanir Pharmaceuticals AVNR AVP-825 (NDA)FDA decision on AVP-825 for the acute treatment of migraine.
-Drug Status

-News
11/23/2014InterMune Inc. ITMN Pirfenidone (NDA resubmission)FDA decision on Pirfenidone for the treatment of idiopathic pulmonary fibrosis FDA approved Pirfenidone under the brand name Esbriet for the treatment of idiopathic pulmonary fibrosis on Oct.15, 2014
-Drug Status

-Approved in Other Countries

11/06/2014Rockwell Medical Technologies Inc RMTI Triferic (NDA) FDA panel to review Triferic for the treatment of iron replacement and maintenance of hemoglobin in hemodialysis patients
11/05/2014AEterna Zentaris Inc AEZ.TO, AEZS Macimorelin Acetate (NDA)FDA decision on Macimorelin Acetate in treating in Adult Growth Hormone Deficiency
10/28/2014Merck & Co Inc. MRK MK-3475 (BLA)FDA decision on MK-3475 for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab FDA approved Keytruda (formerly known as MK-3475) for the treatment of melanoma patients who have not responded to prior therapies on Sep.4, 2014
-Drug Status

10/24/2014NPS Pharmaceuticals Inc NPSP Natpara (BLA)FDA decision on Natpara for the treatment of hypoparathyroidism
10/24/2014Roche Holding AG RHHBY Avastin (sBLA)FDA decision on Avastin plus chemotherapy for the treatment of women with persistent, recurrent or metastaticcervical cancer
10/23/2014Regeneron Pharmaceuticals REGN EYLEA (sBLA)FDA decision on EYLEA for the expanded indication of of Macular Edema following Branch Retinal Vein Occlusion FDA approved EYLEA for macular edema following retinal vein occlusion on Oct.6, 2014
-Approved in Other Countries

-News
10/20/2014Auxilium Pharmaceuticals Inc. AUXL XIAFLEX (sBLA) FDA decision on XIAFLEX for the treatment of two Dupuytren's contracture (DC) cords concurrently FDA approves XIAFLEX for the treatment of two Dupuytren's contracture cords concurrently
-Approved in Other Countries

Previous 15 Records
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