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October 2008
October 1
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
Cell Therapeutics Submits Supplemental Biologics License Application for Zevalin Use in First-Line Consolidation Therapy
October 6
ATryn (antithrombin alfa) BLA Filing Accepted by FDA
October 9
Cardiome Provides Kynapid Regulatory Update
October 10
FDA Continues Review of Takeda's New Drug Application for Alogliptin (SYR-322), a DPP-4 Agent for Type 2 Diabetes
October 13
Acusphere's Imagify to be Reviewed at FDA Advisory Committee Meeting on December 10, 2008
October 14
Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008
October 15
Targanta Announces Review of Oritavancin at FDA Anti-Infective Drugs Advisory Committee Meeting
October 17
Daiichi Sankyo and Lilly Respond to Speculation on Status of Prasugrel New Drug Application
October 20
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
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
NeurogesX Submits NDA for NGX-4010 Dermal Capsaicin Patch for Treatment of Postherpetic Neuralgia (PHN)
October 24
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application to FDA for Carisbamate
October 27
Digestive Care, Inc. Announces the Complete Submission of the NDA for Pancrecarb (pancrelipase)
October 28
Kowa Announces NDA Submission and MAA Filing for HMG CoA Reductase Inhibitor Pitavastatin
October 29
Northfield Laboratories Inc. Announces Submission of BLA for PolyHeme
Cipher Provides CIP-Tramadol ER Regulatory Update
October 31
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
New Drug Applications Archive
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