New Drug Applications: September 2004

September 1	NDA for Cellegesic is Accepted for Review by FDA
September 1	Cilansetron NDA Filing Accepted for Priority Review by the FDA for the Treatment of Irritable Bowel Syndrome with Diarrhea Predominance
September 1	Atrix and Fujisawa Submit New Drug Application for Acne Product
September 1	Exenatide New Drug Application Accepted for Review by the FDA
September 2	FDA Defers Decision on Omnitrope Application
September 2	Pfizer Statement on Regulatory Status of Lyrica
September 8	FDA Accepts Entereg for Review
September 8	CoTherix, Inc. Announces Priority Review Designation by the FDA for Ventavis NDA
September 9	Bonefos Accepted for Filing and Granted Priority Review by FDA
September 10	FDA Advisory Committee Recommends Further Data to Support Approval of AstraZeneca's Oral Anticoagulant Exanta
September 15	FDA Issues Approvable Letter to Berlex Laboratories for Angeliq
September 17	Alcon Receives Approvable Letter for Extravan
September 20	Depomed Announces Proquin XR NDA Accepted by FDA
September 21	Vicuron Pharmaceuticals Provides Update on Anidulafungin Regulatory Paths
September 22	Advisory Panel Recommends FDA Licensure of Aventis' Menactra Vaccine for Protection Against Meningococcal Disease
September 24	Takeda Submits New Drug Application for Ramelteon, an Investigational Sleep Drug
September 27	INEX and Enzon Announce Marqibo to be Reviewed by FDA's Oncologic Drugs Advisory Committee
September 28	ILEX's Clofarabine Scheduled For FDA Advisory Committee Review; ODAC to Review Pivotal Data for Pediatric Acute Leukemia
September 29	Schwarz Pharma Submits Marketing Applications for its Rotigotine Patch 'Neupro'
September 29	NovaDel NDA for Nitroglycerin Lingual Spray is Accepted for Review by FDA
September 30	Amylin Pharmaceuticals Submits Complete Response to FDA for Symlin
September 30	OSI Pharmaceuticals Announces Acceptance of Tarceva New Drug Application for Review by the U.S. Food and Drug Administration

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