New Drug Applications Archive - May 2005
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May 2, 2005
- BDSI Announces Submission of NDA for Emezine; First Transmucosal Product for the Treatment of Nausea and Vomiting
- FDA Accepts Tercica's Increlex New Drug Application With Priority Review for the Treatment of Short Stature
- Merck Submits Biologics License Application to FDA for Zostavax, an Investigational Vaccine for Shingles and Shingles-Associated Nerve Pain
May 3, 2005
- Novartis Files Exjade New Drug Applications for Treatment of Chronic Iron Overload Due to Blood Transfusions
- InKine Announces Submission of a New Drug Application -NDA- for Its Next Generation Purgative Product - INKP-102
May 5, 2005
May 8, 2005
May 11, 2005
- Further Trial Data Awaited for Bonefos in the U.S.
- Vicuron Pharmaceuticals Announces Extension of FDA Review of Dalbavancin New Drug Application
May 19, 2005
May 23, 2005
May 24, 2005
May 25, 2005
- GlaxoSmithKline Submits Biologics License Application for FDA Approval of Fluarix
- Encysive Pharmaceuticals Submits New Drug Application for Thelin
- Barrier Therapeutics Receives Not Approvable Letter From the FDA for Zimycan
May 26, 2005
- Neurocrine Announces Submission of New Drug Application for Indiplon Tablets
- Halozyme Therapeutics Announces FDA Acceptance of Hylenex NDA
May 27, 2005
- Alkermes Announces Priority Review Granted For Vivitrex (Naltrexone Long-Acting Injection) NDA Submission
- Santarus Submits New Drug Application for Zegerid Chewable Tablets
- Biovail Receives Tentative Approval From FDA for Zolpidem ODT for Sleep Disorders
