Advancis Pharmaceutical (AVNC) Receives FDA Acceptance of Amoxicillin PULSYS NDA
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Advancis Pharmaceutical Corporation (Nasdaq: AVNC) announced that the Company's once-daily Amoxicillin PULSYS New Drug Application (NDA) has been accepted for filing by the U.S. Food and Drug Administration (FDA).
As previously reported, Advancis resubmitted its NDA on March 23, 2007, for its once-daily Amoxicillin PULSYS product for the treatment of adolescents and adults with acute pharyngitis/tonsillitis (commonly referred to as strep throat) via the 505(b)(2) regulatory pathway. The FDA has accepted the Company's NDA for filing and has set a Prescription Drug User Fee Act (PDUFA) target action date for the Company's NDA of January 23, 2008.
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