New Drug Applications: February 2008

February 1	Eisai Announces Change in U.S. Submission Schedule for E7389 New Drug Application
February 4	Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA
February 4	Luitpold Pharmaceuticals, Inc., Comment on FDA Advisory Committee Meeting to Evaluate Injectafer (Ferric Carboxymaltose Injection)
February 4	MedImmune Submits Biologics License Application to FDA for Motavizumab
February 6	FDA Agrees to Review Cimzia File for the Treatment of Rheumatoid Arthritis
February 11	FDA Extends Review of NDA for Entereg (alvimopan)
February 11	Targanta Submits Oritavancin New Drug Application
February 12	Watson Announces Silodosin NDA Accepted for Filing by FDA for the Treatment of Benign Prostatic Hyperplasia
February 13	FDA Published Today That It Will Not Hold an Advisory Committee Meeting on Ceftobiprole in the Treatment of Complicated Skin and Skin Structure Infections
February 19	FDA Accepts Treanda New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma
February 19	AMAG Pharmaceuticals, Inc. Announces FDA Acceptance for Filing of Ferumoxytol New Drug Application in Chronic Kidney Disease
February 20	Sciele Provides Update on Head Lice Asphyxiation Product
February 20	Addrenex Pharmaceuticals Reaches Milestone with Filing of NDA for First Product, CloniBID, to Treat Hypertension
February 20	GSK Receives Favorable Recommendation by FDA Advisory Committee for Rotarix (Rotavirus Vaccine, Live, Oral)
February 21	Eurand Granted Priority Review for Zentase NDA
February 21	Forest and Cypress Announce FDA Acceptance for Review of New Drug Application for Milnacipran for the Treatment of Fibromyalgia
February 22	FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, Prasugrel
February 25	Duramed's Lo Seasonique NDA Accepted for Filing by FDA
February 27	Sirion Therapeutics Receives NDA Acceptance and Priority Review From the FDA for Durezol in the Treatment of Postoperative Ocular Inflammation
February 27	FDA Accepts for Review Ovation's Two NDA Submissions for Sabril
February 28	Kyowa Hakko Receives Not Approvable Letter from FDA for Istradefylline (KW-6002)
February 29	Alpharma Submits New Drug Application for Embeda
February 29	PPD Confirms Takeda's NDA Filing of Alogliptin with U.S. Food and Drug Administration

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New Drug Applications: February 2008

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