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October 2007
October 1
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
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
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
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
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
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
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
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
Genta Completes Appeal of FDA Decision for Genasense in CLL
October 29
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
Lev Pharmaceuticals Amends Cinryze BLA to Include Prophylactic Data
MGI Pharma and Helsinn Announce Submission of Supplemental New Drug Application for Aloxi Capsules
October 31
BioDelivery Sciences Submits NDA For BEMA Fentanyl
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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