FDA Calendar


DateCompany NameTickerDrugEventOutcomeDetails
03/05/2015Pacira Pharmaceuticals, Inc. PCRX EXPAREL (sNDA)FDA decision on EXPAREL for use in femoral nerve block for total knee arthroplasty
-Approved in Other Countries

02/28/2015Actavis Plc. ACT Levosert (NDA)FDA decision on Levosert, a hormonal intrauterine contraceptive for use by women to prevent pregnancy.
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. FDA issued second Complete Response Letter for YOSPRALA (PA8140/PA32540) on Dec.17, 2014
-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 FDA approved Ceftolozane/Tazobactam (ZERBAXA) for Complicated Urinary Tract and Complicated Intra-abdominal Infections on Dec.19, 2014
12/05/2014Actavis Plc. ACT Ceftazidime-avibactam (NDA)FDA panel to review Ceftazidime-avibactam for the proposed indications of: Complicated Intra-abdominal Infections, Complicated Urinary Tract Infections FDA panel recommends approval of Ceftazidime-avibactam for Complicated Intra-abdominal Infections and Complicated Urinary Tract Infections
-News
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 FDA approves Jakafi (Ruxolitinib) for the treatment of patients with uncontrolled polycythemia vera
-Approved in Other Countries

-News
11/30/2014Bristol-Myers Squibb Co. BMY Daclatasvir (NDA)FDA decision on Daklinza for the treatment of chronic hepatitis C FDA issues complete response letter for Daclatasvir
-Approved in Other Countries

11/26/2014Avanir Pharmaceuticals AVNR AVP-825 (NDA)FDA decision on AVP-825 for the acute treatment of migraine. FDA issues Complete Response Letter
-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

Previous 15 Records
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