New Drug Applications Archive

New Drug Applications: October 2007

October 1	Surfaxin Process Validation Batches Achieve Stability Milestone to Enable Filing of Response to FDA Approvable Letter
October 1	Endo Pharmaceuticals and Vernalis Receive Action Letter From FDA on Frova Supplemental New Drug Application
October 1	Lev's Cinryze BLA Accepted for Filing by FDA
October 2	Antares Reports Product Progress in Growing Women's Health Portfolio
October 4	Roche and Trimeris Provide Update on Development of Alternative Administration Options for Delivery of Fuzeon
October 4	FzioMed's PMA Application for Oxiplex Gel Accepted for Filing by FDA
October 5	Pozen Plans to Submit Response to Approvable Letter For Trexima Within the Next Ten Days
October 8	Jerini Initiates FDA Submission Process of New Drug Application for Icatibant in the Treatment of HAE
October 10	Angiotech Announces Intent to File 510(k) for its Innovative 5-FU Central Venous Catheter (CVC) Based on Positive Results from Pivotal Trial
October 11	FDA's Psychiatric Division Has Rejected Cortex's Request to Study CX717 in Phase IIb ADHD Study
October 11	Alcon Amends NDA for Patanase Nasal Spray
October 11	FDA Advisory Committee Recommends Medtronic's Endeavor Drug-Eluting Stent for Approval
October 11	Hemispherx Biopharma Files New Drug Application for Ampligen as Treatment for Chronic Fatigue Syndrome
October 12	Gilead Submits Marketing Applications in the United States and European Union for Viread (Tenofovir Disoproxil Fumarate) for the Treatment of Chronic Hepatitis B
October 12	Impending FDA Approval Decision on the First HIV Integrase Inhibitor Isentress Can Have Significant Impact for Patients
October 15	Elan and Biogen Idec Announce That FDA Will Extend Regulatory Review Period for Tysabri for Crohn's Disease
October 15	Pozen Submits Response to Approvable Letter for Trexima
October 15	Labopharm Appeals FDA's Decision on Once-Daily Tramadol
October 17	FDA Advisory Committee Votes in Favor of Earlier Use of Phosphate Binders in Stage 4 Kidney Disease Patients With Hyperphosphatemia
October 19	DOR BioPharma Receives Not Approvable Letter From FDA for orBec for Treatment of Gastrointestinal Graft-vs.-Host Disease
October 22	Abbott and Solvay Pharmaceuticals to co-promote Abbott's Simcor in the United States
October 24	FDA Issues Approvable Letter for Stavzor Delayed Release Valproic Acid Capsules
October 24	Biovail Submits Complete Response to FDA for BVF-033
October 24	FDA Accepts Wyeth's Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
October 25	Genta Completes Appeal of FDA Decision for Genasense in CLL
October 29	Adams Respiratory Therapeutics Receives Approvable Letter From FDA for Mucinex With Codeine
October 29	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	Lev Pharmaceuticals Amends Cinryze BLA to Include Prophylactic Data
October 30	MGI Pharma and Helsinn Announce Submission of Supplemental New Drug Application for Aloxi Capsules
October 31	BioDelivery Sciences Submits NDA For BEMA Fentanyl
October 31	Jerini Submits New Drug Application for Icatibant in the Treatment of HAE to the FDA and Requests Priority Review

New Drug Applications Archive

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