New Drug Applications Archive - May 2007
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May 1, 2007
May 4, 2007
May 7, 2007
- MGI Pharma and Helsinn Announce Submission of Supplemental New Drug Application for Aloxi Injection in Post-Operative Nausea and Vomiting
- Abbott Seeks U.S. and E.U. Regulatory Approvals for Humira (Adalimumab) as a Treatment for Juvenile Rheumatoid Arthritis
May 8, 2007
May 9, 2007
- Dendreon Receives Complete Response Letter From FDA for Provenge Biologics License Application
- Somaxon Pharmaceuticals Provides Update on Silenor Development Program
- FDA Advisory Committee Reviews Data on IDM Pharma's Junovan (mifamurtide) for Treatment of Osteosarcoma
May 14, 2007
- Merck Receives Approvable Letter from FDA for Emend (fosaprepitant dimeglumine) For Injection
- Luitpold Pharmaceuticals, Inc., Announces NDA Submission for Injectafer (Ferric Carboxymaltose Injection), a Next Generation Intravenous Iron Product
- Questcor Receives FDA Action Letter for H.P. Acthar Gel for Treatment of Infantile Spasms
May 15, 2007
May 16, 2007
- New Free White Paper Addresses Challenges of New FDA RegulationsAwaiting Combo Product Manufacturers
- FDA Advisory Committee Recommends Expanded Use of FluMist
May 18, 2007
- FDA Advisory Committee Unanimously Votes in Favor of Acambis' Smallpox Vaccine
- New Drug Application Submitted For Novel Investigational Antibiotic Ceftobiprole
May 21, 2007
- Roche Receives Approvable Letter for Mircera in the United States
- FDA Issues Approvable Letter for SPD465 (Triple-Bead Mixed Amphetamine Salts) for the Treatment of ADHD in Adults
- Single-Tablet Combination of Tekturna and Diuretic, an Important New Option for People With High Blood Pressure, Accepted for Review in U.S.
May 22, 2007
May 24, 2007
May 29, 2007
- MedImmune Receives Correspondence From FDA Regarding FluMist
- QLT USA, Inc. files Aczone labeling supplement for removal of blood screening requirement
