New Drug Applications Archive - October 2007
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October 1, 2007
- Surfaxin Process Validation Batches Achieve Stability Milestone to Enable Filing of Response to FDA Approvable Letter
- Endo Pharmaceuticals and Vernalis Receive Action Letter From FDA on Frova Supplemental New Drug Application
- Lev's Cinryze BLA Accepted for Filing by FDA
October 2, 2007
October 4, 2007
- Roche and Trimeris Provide Update on Development of Alternative Administration Options for Delivery of Fuzeon
- FzioMed's PMA Application for Oxiplex Gel Accepted for Filing by FDA
October 5, 2007
October 8, 2007
October 10, 2007
October 11, 2007
- FDA's Psychiatric Division Has Rejected Cortex's Request to Study CX717 in Phase IIb ADHD Study
- Alcon Amends NDA for Patanase Nasal Spray
- FDA Advisory Committee Recommends Medtronic's Endeavor Drug-Eluting Stent for Approval
- Hemispherx Biopharma Files New Drug Application for Ampligen as Treatment for Chronic Fatigue Syndrome
October 12, 2007
- Gilead Submits Marketing Applications in the United States and European Union for Viread (Tenofovir Disoproxil Fumarate) for the Treatment of Chronic Hepatitis B
- Impending FDA Approval Decision on the First HIV Integrase Inhibitor Isentress Can Have Significant Impact for Patients
October 15, 2007
- Elan and Biogen Idec Announce That FDA Will Extend Regulatory Review Period for Tysabri for Crohn's Disease
- Pozen Submits Response to Approvable Letter for Trexima
- Labopharm Appeals FDA's Decision on Once-Daily Tramadol
October 17, 2007
October 19, 2007
October 22, 2007
October 24, 2007
- FDA Issues Approvable Letter for Stavzor Delayed Release Valproic Acid Capsules
- Biovail Submits Complete Response to FDA for BVF-033
- FDA Accepts Wyeth's Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
October 25, 2007
October 29, 2007
- Adams Respiratory Therapeutics Receives Approvable Letter From FDA for Mucinex With Codeine
- Elan Announces the Johnson & Johnson Pharmaceutical Research & Development Submission of a New Drug Application to the FDA for Paliperidone Palmitate Using Elan's Proprietary NanoCrystal Technology
October 30, 2007
- Lev Pharmaceuticals Amends Cinryze BLA to Include Prophylactic Data
- MGI Pharma and Helsinn Announce Submission of Supplemental New Drug Application for Aloxi Capsules
