New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

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 Luitpold Pharmaceuticals, Inc., Comment on FDA Advisory Committee Meeting to Evaluate Injectafer (Ferric Carboxymaltose Injection) 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) 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 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 Addrenex Pharmaceuticals Reaches Milestone with Filing of NDA for First Product, CloniBID, to Treat Hypertension GSK Receives Favorable Recommendation by FDA Advisory Committee for Rotarix (Rotavirus Vaccine, Live, Oral)

February 21

Eurand Granted Priority Review for Zentase NDA 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 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 PPD Confirms Takeda's NDA Filing of Alogliptin with U.S. Food and Drug Administration

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