New Drug Applications: March 2008

March 3	FDA Grants Priority Review for Promacta (eltrombopag)
March 6	FDA Accepts for Review Theravance's Complete Response to Approvable Letter for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections
March 6	CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
March 7	Hemispherx Biopharma Reaches Agreement With FDA on Specific Steps to Achieve Complete NDA on Proposed CFS Treatment Ampligen
March 12	FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
March 12	Amgen to Discuss Romiplostim Application at FDA ODAC Meeting
March 12	Luitpold Pharmaceutical’s Injectafer (ferric carboxymaltose injection) Receives Non-Approvable Letter From FDA
March 13	Neurochem Moves Eprodisate (Kiacta) Drug Development Program Forward for Amyloid A Amyloidosis
March 13	Lev Announces FDA's Blood Products Advisory Committee to Review Cinryze (C1 inhibitor)
March 13	Amgen Statement on Successful Outcome of Romiplostim Panel Meeting
March 17	FDA Indicates That Genasense Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data
March 17	Ipsen and Medicis announce submission of Reloxin BLA in aesthetics to the FDA
March 18	FDA Issues Approvable Letter for Ceftobiprole for Treatment of Complicated Skin Infections
March 19	Arpida Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections
March 24	SIGA Files Application Supporting Emergency Use Approval for ST-246

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New Drug Applications: March 2008

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