New Drug Applications Archive - July 2008
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July 1, 2008
- EPIX Pharmaceuticals Announces Resubmission of New Drug Application for Vasovist
- Alpharma Announces the Resubmission of a New Drug Application for Embeda Capsules
- ChemGenex Announces Submission of Non-Clinical Section of Rolling NDA for Omacetaxine
- VioQuest Pharmaceuticals Submits 510(k) Application to FDA for Xyfid, a Novel Topical Agent for the Treatment of Various Skin Disorders
July 3, 2008
July 7, 2008
July 14, 2008
- FDA Accepts Genta's NDA Amendment as Complete Response for Genasense Treatment of Chronic Lymphocytic Leukemia
- FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP
July 15, 2008
July 16, 2008
July 17, 2008
July 22, 2008
July 23, 2008
- NexMed Receives FDA Response for Topical ED Product
- Bristol-Myers Squibb and AstraZeneca Submit New Drug Application in the United States and Marketing Authorization Application in Europe for Onglyza (saxagliptin) for the Treatment of Type 2 Diabetes
July 24, 2008
July 28, 2008
- Eisai Receives Action Letter on Fospropofol Disodium Injection for Sedation in Diagnostic or Therapeutic Procedures
- CVT Announces That FDA Continues to Review Ranexa Applications
- Vanda Pharmaceuticals Announces Receipt of Not Approvable Letter From FDA for Iloperidone
July 29, 2008
- Meda: The FDA has accepted for filing the registration application for Sublinox
- UCB Receives Not-Approvable Letter from FDA for Lacosamide for Diabetic Neuropathic Pain
- FDA Advisory Committee Recommends Approval of Actemra (tocilizumab) for the Treatment of Rheumatoid Arthritis
