New Drug Applications Archive - December 2013
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December 2, 2013
December 9, 2013
December 10, 2013
December 11, 2013
- Sprout Pharmaceuticals Appeals FDA Decision on NDA for Flibanserin to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women
- Orexigen Resubmits Contrave New Drug Application
- QRxPharma Announces 25 May 2014 as New PDUFA Date for MoxDuo NDA
- FDA Grants Priority Review for Genzyme’s Cerdelga (eliglustat), an Investigational Oral Therapy for Gaucher Disease
December 12, 2013
- FDA Advisory Committee Votes on Investigational Medicine Metreleptin
- FDA Issues Complete Response Letter for Canagliflozin/Metformin Fixed-Dose Combination Therapy for Type 2 Diabetes
- FDA Advisory Committee Recommends the Investigational SGLT2 Inhibitor Dapagliflozin for Treatment of Type 2 Diabetes in Adults
