New Drug Applications Archive

New Drug Applications: November 2007

November 1	FDA Accepts New Drug Application for Nebido Submitted by Indevus
November 1	King Pharmaceuticals Files Citizen Petition with FDA Asserting ZymoGenetics Has Not Submitted Adequate Data for Approval of Its Recombinant Thrombin Product
November 1	Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA
November 1	Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants
November 2	PDUFA Date for Rilonacept (IL-1 Trap) Extended Three Months by FDA
November 5	Fabre Kramer Pharmaceuticals Receives Decision From FDA on Gepirone ER for Major Depressive Disorder
November 5	Abbott Confirms FDA Advisory Panel to Review XIENCE V Drug Eluting Stent on November 29
November 6	Camargo Pharmaceutical Services Announces Education Series on FDA 505(b)(2) Approval Route
November 12	Cephalon Submits Supplemental New Drug Application for Fentora
November 13	Genzyme Receives FDA Response Letter on Synvisc-One
November 14	Rimonabant - Regulatory Update in Europe
November 15	Abilify (aripiprazole) Supplemental New Drug Application for the Treatment of Pediatric Patients with Bipolar I Disorder Accepted for Priority Review by the U.S. Food and Drug Administration
November 16	Discovery Labs' Response to Surfaxin Approvable Letter Deemed Complete by FDA
November 16	Gilead Submits New Drug Application to U.S. FDA for Aztreonam Lysine for Inhalation for Cystic Fibrosis
November 19	Amarin Announces Completion of Comprehensive Data Analysis From Phase III Huntington's Disease Program
November 20	Biovail Confirms FDA Class 2 Status For BVF-033 Submission
November 20	FDA Accepts Ranexa sNDA and NDA for Filing
November 20	NexMed Confirms FDA Acceptance of NDA for Erectle Dysfunction Product
November 21	Roche Submits Application for FDA Approval of Actemra for the Treatment of Rheumatoid Arthritis
November 26	Schering-Plough Announces Asenapine NDA Accepted for Filing by the U.S. FDA
November 26	PARI's eFlow Included in Gilead's NDA Submission for Aztreonam Lysine for Inhalation
November 27	Vanda Pharmaceuticals Receives FDA Acceptance of Iloperidone New Drug Application
November 28	UCB Announces FDA Filing for lacosamide in the Treatment of Diabetic Neuropathic Pain
November 28	Adolor and GlaxoSmithKline Announce FDA Advisory Committee to Review Entereg (alvimopan) for the Management of Postoperative Ileus (POI)
November 29	UCB Announces FDA Filing for lacosamide in the Treatment of Partial Onset Seizures in Adults with Epilepsy

New Drug Applications Archive

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