New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

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 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 Amgen to Discuss Romiplostim Application at FDA ODAC Meeting 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 Lev Announces FDA's Blood Products Advisory Committee to Review Cinryze (C1 inhibitor) 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 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

New Drug Applications Archive

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