New Drug Applications Archive - March 2008
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March 3, 2008
March 6, 2008
- FDA Accepts for Review Theravance's Complete Response to Approvable Letter for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections
- CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
March 7, 2008
March 12, 2008
- Amgen to Discuss Romiplostim Application at FDA ODAC Meeting
- FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
- Luitpold Pharmaceutical’s Injectafer (ferric carboxymaltose injection) Receives Non-Approvable Letter From FDA
March 13, 2008
- Neurochem Moves Eprodisate (Kiacta) Drug Development Program Forward for Amyloid A Amyloidosis
- Lev Announces FDA's Blood Products Advisory Committee to Review Cinryze (C1 inhibitor)
- Amgen Statement on Successful Outcome of Romiplostim Panel Meeting
March 17, 2008
- FDA Indicates That Genasense Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data
- Ipsen and Medicis Announce Submission of Reloxin BLA in Aesthetics to the FDA
