New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

September 2008

September 2

Alpharma Announces Acceptance of the Embeda Capsule NDA Filing Introgen Receives Notice Advexin U.S. BLA Not Sufficiently Complete to File

September 3

ImClone Submits Supplemental Biologics License Application for Erbitux in First-Line Head and Neck Cancer Inhaled Treprostinil New Drug Application Filed by FDA

September 8

Ortho Biotech Files sNDA for Doxil for the Treatment of Advanced Breast Cancer

September 9

Pfizer Will Withdraw Global Marketing Applications for Dalbavancin to Conduct a New Trial

September 15

Pro-Pharmaceuticals Submits Data to FDA for Davanat NDA to Treat Advanced Colorectal Cancer Lundbeck Submits New Drug Application (NDA) for Serdolect in the US for the Treatment of Schizophrenia Cephalon Receives Complete Response Letter Regarding Request for Expanded Fentora Label for Non-Cancer Breakthrough Pain FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter

September 16

GSK and XenoPort Announce Submission of NDA Requesting FDA Approval of Solzira for Restless Legs Syndrome

September 17

Daiichi Sankyo, Inc. Files Supplemental New Drug Application for Azor as Initial Therapy for High Blood Pressure Gilead Receives Complete Response Letter from U.S. Food and Drug Administration for Aztreonam Lysine for Inhalation, an Investigational Treatment for Cystic Fibrosis

September 18

FDA Issues Complete Response Letter to Roche for Acterma (tocilizumab) Biologics License Application

September 19

NovaDel Pharma Announces PDUFA Deadline Extension on Zolpimist

September 22

Labopharm Submits New Drug Application to FDA for DDS-04A to Treat Major Depression

September 23

FDA Accepts New Drug Application for Bucindolol, A Genetically-Targeted Treatment for Heart Failure From ARCA biopharma Genzyme Announces FDA Priority Review for Mozobil New Drug Application

September 24

Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema Takeda Submits a New Drug Application in the U.S. for Alogliptin (SYR-322) / Actos (pioglitazone HCl) for the Treatment of Type 2 Diabetes Discovery Labs Reports Technical Achievements Towards Gaining FDA Approval of Surfaxin

September 26

Indevus and FDA Agree on Path Forward for Nebido

September 29

FDA Continues to Review Prasugrel New Drug Application

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