New Drug Applications: December 2004

December 1	FDA Issues Approvable Letter for Yamanouchi's Investigational Hyponatremia Treatment Conivaptan Hydrochloride Injection
December 1	FDA Advisory Committee Recommends Accelerated Clofarabine Approval for Most Common Pediatric Leukemia; FDA to Make Approval Decision by End of Year
December 1	INEX and ENZON Announce ODAC Does Not Support Accelerated Approval for Cancer Drug Marqibo
December 3	Pfizer Submits Regulatory Filings for Revatio as a Treatment for Pulmonary Arterial Hypertension
December 3	BioSante Pharmaceuticals Comments on FDA Advisory Committee's Decision Not to Recommend Approval of Testosterone Patch
December 4	New Drug Application Submitted for Dapoxetine for Premature Ejaculation
December 8	New Drug Application Submitted to FDA for Intravenous Injection of Boniva
December 14	Abbott Submits New Drug Application to U.S. FDA for Advanced Prostate Cancer Drug, Xinlay (atrasentan)
December 15	Chiron Receives FDA Priority Review Designation for New Drug Application for Pulminiq -- Cyclosporine, USP-- Inhalation Solution
December 15	Wyeth Seeks Global Regulatory Approval of Tygacil (Tigecycline) for Injection
December 15	TAP Submits New Drug Application for Febuxostat for the Management of Hyperuricemia in Chronic Gout
December 16	AVANIR Announces Submission of Rolling NDA With Priority Review for Neurodex
December 16	Alcon Submits Retaane - Drug Applications to U.S. and European Regulatory Authorities
December 20	Solvay Pharmaceuticals, Inc. Announces 90-Day Extension of FDA Review of the New Drug Application for Cilansetron for the Treatment of Irritable Bowel Syndrome with Diarrhea Predominance (IBS-D)
December 21	Indiplon IR NDA (New Drug Application) to Be Reformatted Due to Difficulties in Accessing Portions of the Electronic NDA
December 21	Cephalon Files Application for Marketing Approval of New Modafinil Formulation for the Treatment of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder
December 21	POZEN's MT 100 To Be Reviewed by Advisory Committee in May 2005
December 21	Vicuron Pharmaceuticals Submits New Drug Application for Dalbavancin to U.S. Food and Drug Administration
December 22	Duramed's Seasonique NDA Accepted for Filing by FDA
December 23	FDA Issues Not Approvable Letter for Cellegesic
December 23	Bristol-Myers Squibb Provides Regulatory Update for Muraglitazar
December 23	Bristol-Myers Squibb Provides Regulatory Update for Abatacept
December 23	NitroMed Submits BiDil New Drug Application Amendment; Company Prepares for Commercialization of First Heart Failure Treatment for African Americans

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New Drug Applications: December 2004

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