New Drug Applications Archive - February 2008
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February 1, 2008
February 4, 2008
- 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, 2008
February 11, 2008
February 12, 2008
February 13, 2008
February 19, 2008
- 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, 2008
- 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, 2008
- 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, 2008
February 25, 2008
February 27, 2008
- 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
