New Drug Applications Archive - August 2011
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August 1, 2011
August 2, 2011
August 3, 2011
August 5, 2011
- Alexza Announces Resubmission of AZ-004 (Staccato Loxapine) NDA
- Affymax and Takeda Announce FDA Acceptance of New Drug Application for Peginesatide
August 8, 2011
August 9, 2011
August 10, 2011
- Adventrx Receives Complete Response Letter for Exelbine NDA
- Bydureon FDA Action Date Set for January 28, 2012
August 11, 2011
- MAP Pharmaceuticals Issued U.S. Patent for Methods of Achieving Rapid Relief of Migraine and Minimizing Side Effects Based Upon Pharmacokinetic Profile
- Affymax Announces Assignment of March 27, 2012 PDUFA Date for Peginesatide New Drug Application
August 12, 2011
August 17, 2011
- Protalix BioTherapeutics Announces FDA Accepts for Review Complete Response Resubmission for Taliglucerase Alfa and Assigns PDUFA Date
- Regeneron Announces Review of Biologics License Application for Eylea (aflibercept injection) Extended by Three Months by FDA
August 18, 2011
August 19, 2011
August 24, 2011
August 26, 2011
August 29, 2011
- Astellas Pharma Inc.: Announcement of Regulatory Submission for Mirabegron (YM178), a Treatment for Overactive Bladder, in U.S. and Europe
- FDA Requests Additional Clinical Data on Novartis Drug ACZ885 for the Treatment of Gouty Arthritis
