New Drug Applications Archive

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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

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