Regulatory Actions
Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008
Published in Medical Letter on the CDC and FDA, November 2nd, 2008
Arpida Ltd. (SWX: ARPN) announced that it has received notice from the U.S. Food and Drug Administration (FDA) that the agency's Anti-Infective Drugs Advisory Committee will discuss the New Drug Application (NDA) for intravenous iclaprim in complicated Skin and Skin Structure Infections (cSSSI) during its meeting on 18-20 November 2008. An Advisory Committee can be requested by FDA as part of the review process of an NDA or supplemental NDA.
Iclaprim is a hospital antibiotic drug candidate with potent bactericidal (killing) activity against MRSA and an extended range of important pathogens. To date, Arpida has filed marketing applications for intravenous iclaprim in the...
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