New Drug Applications Archive - February 2012
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February 1, 2012
February 7, 2012
- Salix Pharmaceuticals Announces FDA Granting of Priority Review Designation for the Crofelemer NDA for Treatment of Diarrhea in Patients with HIV/AIDS on Anti-Retroviral Therapy
- FDA Grants Genentech's Pertuzumab Priority Review for Previously Untreated HER2-Positive Metastatic Breast Cancer
February 8, 2012
February 14, 2012
February 15, 2012
- Santarus Announces FDA Acceptance of Uceris New Drug Application for Induction of Remission of Active Ulcerative Colitis
- FDA Accepts Pfizer's New Drug Application for Tafamidis Meglumine, a Novel, Investigational Treatment for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP)
February 23, 2012
- FDA Advisory Committee Recommends Approval of Qnexa
- FDA Accepts Impax Pharmaceuticals NDA Filing for IPX066 for the Treatment of Idiopathic Parkinson's Disease
February 24, 2012
- Forest and Almirall Announce Positive FDA Advisory Committee's Recommendation for Approval of Aclidinium Bromide for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
- FDA Advisory Panel Recommends Approval of Chelsea's Northera (droxidopa) for the Treatment of Symptomatic Neurogenic OH
