New Drug Applications Archive - January 2011
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January 5, 2011
January 6, 2011
- Boceprevir, Merck's Investigational Oral Hepatitis C Protease Inhibitor, Receives FDA Priority Review and EMA Accelerated Assessment
- ChemGenex Announces alignment of European and US regulatory strategies for omacetaxine
January 7, 2011
January 10, 2011
- EffRx Pharmaceuticals SA Announces Submission of New Drug Application to FDA for Osteoporosis Treatment Targeting Increased Convenience for Patients
- Discovery Labs Provides Update Regarding Its Program for Surfaxin U.S. Marketing Authorization
January 11, 2011
January 12, 2011
- Pfizer Initiates Rolling Submission For A New Drug Application In The U.S. For Its Fast-Tracked Investigational Compound Crizotinib (PF-02341066) For Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer
- Fibrocell Science, Inc. Announces FDA Accepts for Review Complete Response Submission for Azficel-T
- FDA Agrees to Special Protocol Assessment (SPA) to Evaluate the Safety and Efficacy of a Fixed-Dose Combination (FDC) of Netupitant and Palonosetron in the Prevention of CINV
- K-V Pharmaceutical Company Updates Status of New Drug Application for Gestiva
January 13, 2011
January 18, 2011
January 19, 2011
January 20, 2011
- U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C
- MannKind Corporation Receives Complete Response Letter from the FDA for Afrezza
- Adventrx Pharmaceuticals Receives PDUFA Date for Exelbine NDA
January 21, 2011
- VIVUS Provides Regulatory Update on Qnexa NDA
- AstraZeneca Replies to the US FDA Complete Response Letter for Brilinta (Ticagrelor Tablets)
