New Drug Applications: October 2008

October 1	Advanced Life Sciences Announces NDA Submission for Cethromycin in Community Acquired Pneumonia
October 1	New Drug Application (NDA) for Lipsovir submitted to US FDA
October 1	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
October 20	AMAG Pharmaceuticals Receives Complete Response Letter from FDA for Ferumoxytol
October 20	Discovery Labs Submits Complete Response to May 2008 FDA Approvable Letter for Surfaxin for RDS
October 20	NexMed Discusses End of Review Meeting for Vitaros
October 20	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
October 21	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
October 29	Cipher Provides CIP-Tramadol ER Regulatory Update
October 31	Spectrum Pharmaceuticals Files Supplemental New Drug Application with FDA for Fusilev in Colorectal Cancer
October 31	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
October 31	Savient Submits Biologics License Application (BLA) for Pegloticase

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New Drug Applications: October 2008

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