New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

November 2007

November 1

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

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 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 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 FDA Accepts Ranexa sNDA and NDA for Filing 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 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 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

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