FDA Calendar

Advisory Committee and PDUFA Date Activity

Generic Name              Trade Name           Originator                                                 Indication                                                                            Date

Fentanyl SL Spray                                 Insys Therapeutics Inc cancer pain 01/04/2012 PDUFA

Progesterone PROCHIEVE Columbia Laboratories Inc reduction of risk of preterm birth 01/20/2012 AdComm
Dapagliflozin Bristol-Myers Squibb Co. type 2 diabetes mellitus 01/28/2012 PDUFA
exenatide Bydureon Amylin Pharmaceuticals Inc type 2 diabetes 01/28/2012 PDUFA
Taliglucerase Alfa Uplyso PROTALIX BIOTHERAPEUTICS Gaucher disease 02/01/2012 PDUFA
capsaicin Qutenza NeurogesX Inc HIV-Associated Peripheral Neuropathy 02/09/2012 AdComm
testosterone gel Bio-T-Gel biosante pharmaceuticals inc. male hypogonadism or low testosterone levels 02/14/2012 PDUFA
mifepristone Corlux Corcept Therapeutics Inc Cushing’s Syndrome 02/17/2012 PDUFA
phentermine and topiramate Qnexa VIVUS INC obesity 02/22/2012 AdComm
progesterone PROCHIEVE Columbia Laboratories Inc reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy 02/26/2012 PDUFA
lucinactant Surfaxin Discovery Laboratories Inc respiratory distress syndrome in premature infants 03/06/2012 PDUFA
capsaicin topical Qutenza NeurogesX Inc neuropathic pain associated with HIV-associated peripheral neuropathy 03/07/2012 PDUFA
Vismodegib Curis Inc advanced Basal Cell Carcinoma 03/08/2012 PDUFA
dihydroergotamine Levadex NDA MAP PHARMACEUTICALS, migraine in adults 03/26/2012 PDUFA
Peginesatide Hematide AFFYMAX INC anemia associated with CKD patients on dialysis 03/27/2012 PDUFA
apixaban ELIQUIS Bristol-Myers Squibb Co. prevention of stroke and systemic embolism in patients with atrial fibrillation 03/28/2012 PDUFA
droxidopa Northera Chelsea Therapeutics International symptomatic neurogenic orthostatic hypotension 03/28/2012 PDUFA

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