FDA Calendar


DateCompany NameTickerDrugEventOutcomeDetails
02/06/2015Roche Holding AG RHHBY Lucentis (sBLA)FDA decision on Lucentis for the treatment of diabetic retinopathy
-Drug Status

01/24/2015Rockwell Medical Technologies Inc RMTI Triferic (NDA) FDA decision on Triferic for the treatment of iron replacement and maintenance of hemoglobin in hemodialysis patients
01/24/2015Rockwell Medical Technologies Inc RMTI Triferic (NDA)FDA decision on Triferic for treating iron deficiency in chronic kidney disease patients on hemodialysis
01/09/2015Impax Laboratories Inc IPXL RYTARY (NDA)FDA decision on RYTARY for the treatment of idiopathic Parkinson's disease
-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
12/30/2014POZEN 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
12/23/2014Biocryst 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. FDA decision likely to be delayed
-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 FDA panel recommends approval of Triferic for the treatment of iron replacement and maintenance of hemoglobin in hemodialysis patients
-News
11/05/2014AEterna Zentaris Inc AEZ.TO, AEZS Macimorelin Acetate (NDA)FDA decision on Macimorelin Acetate in treating in Adult Growth Hormone Deficiency FDA issues complete response letter for Macimorelin Acetate
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 FDA decision on Natpara postponed to January 24, 2015.
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