FDA Calendar

DateCompany NameTickerDrugEventOutcomeDetails
10/20/2014Auxilium Pharmaceuticals Inc. AUXL XIAFLEX (sBLA) FDA decision on XIAFLEX for the treatment of two Dupuytren's contracture (DC) cords concurrently
10/10/2014Gilead Sciences Inc. GILD Ledipasvir/Sofosbuvir (NDA)FDA decision on Ledipasvir/Sofosbuvir for chronic hepatitis C genotype 1 infection
10/07/2014Pharmacyclics Inc. PCYC IMBRUVICA (sNDA)FDA decision on IMBRUVICA in the treatment of patients with chronic lymphocytic leukemia and small lymphocytic lymphoma who have received at least one prior therapy for a full approval.
10/04/2014Gilead Sciences Inc. GILD Elvitegravir (NDA resubmission) FDA decision on Elvitegravir or the treatment of HIV-1 infection in treatment-experienced adults
-Approved in Other Countries

10/03/2014Gilead Sciences Inc. GILD Cobicistat (NDA resubmission)FDA decision on Cobicistat as a boosting agent for HIV therapy
-Approved in Other Countries

09/26/2014pSivida Limited PSDV ILUVIEN (NDA resubmission)FDA decision on ILUVIEN for treatment of Diabetic Macular Edema
09/18/2014MEDIVATION INC MDVN XTANDI (sNDA)FDA decision on XTANDI for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy
-Drug Status

09/15/2014Salix Pharmaceuticals Ltd SLXP Budesonide 2 mg Rectal Foam (NDA) FDA decision on Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis
09/12/2014NPS Pharmaceuticals Inc NPSP Natpara (BLA)FDA panel to review Natpara for the treatment of hypoparathyroidism
09/07/2014Keryx Biopharmaceuticals Inc KERX Zerenex (NDA)FDA decision on Zerenex for the treatment of hyperphosphatemia in dialysis-dependent chronic kidney disease (CKD) patients
08/18/2014Regeneron Pharmaceuticals REGN EYLEA (sBLA)FDA decision on EYLEA for the additional indication of diabetic macular edema
08/09/2014Spectrum Pharmaceuticals Inc SPPI Beleodaq (NDA)FDA decision on Beleodaq for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma FDA approved Beleodaq for relapsed or refractory peripheral T-cell lymphoma on Jul.3, 2014, well ahead of the decision date
08/06/2014The Medicines Co. MDCO Oritavancin (NDA)FDA decision on Oritavancin for the treatment of acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria
08/06/2014Flamel Technologies SA FLML Unapproved Marketed Drug (Resubmitted NDA)FDA decision on Unapproved Marketed Drug
07/31/2014Halozyme Therapeutics, Inc. HALO HYQVIA (BLA)FDA panel to review HYQVIA for patients with primary immunodeficiency
Previous 15 Records
comments powered by Disqus