New Drug Applications Archive - October 2008
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October 1, 2008
- Advanced Life Sciences Announces NDA Submission for Cethromycin in Community Acquired Pneumonia
- New Drug Application (NDA) for Lipsovir submitted to US FDA
- Transcept Pharmaceuticals Submits New Drug Application for Intermezzo for Treatment of Middle-of-the-Night Awakenings
October 2, 2008
October 6, 2008
October 9, 2008
October 10, 2008
October 13, 2008
October 14, 2008
October 15, 2008
October 17, 2008
October 20, 2008
- FDA Adds Three Months to Review of Takeda's New Drug Application for TAK-390MR
- AMAG Pharmaceuticals Receives Complete Response Letter from FDA for Ferumoxytol
- Discovery Labs Submits Complete Response to May 2008 FDA Approvable Letter for Surfaxin for RDS
- NexMed Discusses End of Review Meeting for Vitaros
- FDA Defers Final Action on Milnacipran New Drug Application
October 21, 2008
- Intercell making strides towards imminent approval of its Japanese Encephalitis vaccine in the United States –Approvals in United States, Europe and Australia remain on track for 2008
- KV Provides Update on Gestiva PDUFA Date
October 22, 2008
October 24, 2008
October 27, 2008
October 28, 2008
October 29, 2008
- Northfield Laboratories Inc. Announces Submission of BLA for PolyHeme
- Cipher Provides CIP-Tramadol ER Regulatory Update
October 31, 2008
- Spectrum Pharmaceuticals Files Supplemental New Drug Application with FDA for Fusilev in Colorectal Cancer
- Erbitux Supplemental Biologics License Application for First-Line Recurrent or Metastatic Head and Neck Cancer Accepted for Priority Review by U.S. Food and Drug Administration
- Savient Submits Biologics License Application (BLA) for Pegloticase
