May 16, 2008 -- Arpida Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for intravenous iclaprim in the treatment of complicated Skin and Skin Structure Infections (cSSSI). Arpida completed the submission of the NDA to the agency in March 2008. FDA has assigned a standard ten month review to the iclaprim NDA and has established the Prescription Drug User Fee Act (PDUFA) action date for the NDA to be 16 January 2009.
The details can be read here.
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