Antares Pharma Announces FDA Acceptance of Anturol NDA for Filing

Antares Pharma, Inc. AIS today announced the New Drug Application (NDA) for Anturol® Gel in patients with overactive bladder was accepted for filing for review by the U.S. Food and Drug Administration. Anturol is an oxybutynin gel incorporating Antares' ATD Gel technology. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 8, 2011, ten months from the official NDA filing. The PDUFA date is the target date for the FDA to complete its review of the NDA.