New Drug Applications Archive - December 2004
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December 1, 2004
- FDA Issues Approvable Letter for Yamanouchi's Investigational Hyponatremia Treatment Conivaptan Hydrochloride Injection
- FDA Advisory Committee Recommends Accelerated Clofarabine Approval for Most Common Pediatric Leukemia; FDA to Make Approval Decision by End of Year
- INEX and ENZON Announce ODAC Does Not Support Accelerated Approval for Cancer Drug Marqibo
December 3, 2004
- Pfizer Submits Regulatory Filings for Revatio as a Treatment for Pulmonary Arterial Hypertension
- BioSante Pharmaceuticals Comments on FDA Advisory Committee's Decision Not to Recommend Approval of Testosterone Patch
December 4, 2004
December 14, 2004
December 15, 2004
- Chiron Receives FDA Priority Review Designation for New Drug Application for Pulminiq -- Cyclosporine, USP-- Inhalation Solution
- TAP Submits New Drug Application for Febuxostat for the Management of Hyperuricemia in Chronic Gout
- Wyeth Seeks Global Regulatory Approval of Tygacil (Tigecycline) for Injection
December 16, 2004
- Alcon Submits Retaane - Drug Applications to U.S. and European Regulatory Authorities
- AVANIR Announces Submission of Rolling NDA With Priority Review for Neurodex
December 20, 2004
December 21, 2004
- Cephalon Files Application for Marketing Approval of New Modafinil Formulation for the Treatment of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder
- Indiplon IR NDA (New Drug Application) to Be Reformatted Due to Difficulties in Accessing Portions of the Electronic NDA
- POZEN's MT 100 To Be Reviewed by Advisory Committee in May 2005
- Vicuron Pharmaceuticals Submits New Drug Application for Dalbavancin to U.S. Food and Drug Administration
December 22, 2004
December 23, 2004
- Bristol-Myers Squibb Provides Regulatory Update for Muraglitazar
- Bristol-Myers Squibb Provides Regulatory Update for Abatacept
- NitroMed Submits BiDil New Drug Application Amendment; Company Prepares for Commercialization of First Heart Failure Treatment for African Americans
- FDA Issues Not Approvable Letter for Cellegesic
