New Drug Applications Archive - November 2007
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November 1, 2007
- FDA Accepts New Drug Application for Nebido Submitted by Indevus
- King Pharmaceuticals Files Citizen Petition with FDA Asserting ZymoGenetics Has Not Submitted Adequate Data for Approval of Its Recombinant Thrombin Product
- Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants
- Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA
November 2, 2007
November 5, 2007
- Fabre Kramer Pharmaceuticals Receives Decision From FDA on Gepirone ER for Major Depressive Disorder
- Abbott Confirms FDA Advisory Panel to Review XIENCE V Drug Eluting Stent on November 29
November 6, 2007
November 12, 2007
November 13, 2007
November 14, 2007
November 15, 2007
November 16, 2007
- Discovery Labs' Response to Surfaxin Approvable Letter Deemed Complete by FDA
- Gilead Submits New Drug Application to U.S. FDA for Aztreonam Lysine for Inhalation for Cystic Fibrosis
November 19, 2007
November 20, 2007
- Biovail Confirms FDA Class 2 Status For BVF-033 Submission
- FDA Accepts Ranexa sNDA and NDA for Filing
- NexMed Confirms FDA Acceptance of NDA for Erectle Dysfunction Product
November 21, 2007
November 26, 2007
- Schering-Plough Announces Asenapine NDA Accepted for Filing by the U.S. FDA
- PARI's eFlow Included in Gilead's NDA Submission for Aztreonam Lysine for Inhalation
November 27, 2007
November 28, 2007
- UCB Announces FDA Filing for lacosamide in the Treatment of Diabetic Neuropathic Pain
- Adolor and GlaxoSmithKline Announce FDA Advisory Committee to Review Entereg (alvimopan) for the Management of Postoperative Ileus (POI)
