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Antares Pharma Inc. (AIS) Gets New Drug Application Approval from FDA

Antares Pharma Inc., a company focused on self-injection pharmaceutical products and topical gel-based medicines, today announced that the New Drug Application (NDA) for Anturol® Gel as treatment for patients with overactive bladder (OAB) was accepted for filing for review by the U.S. Food and Drug Administration (FDA).

Anturol, a gel applied to the skin to treat OAB, incorporates Antares’ ATD Gel technology. Acceptance by the FDA marks an important milestone for the company as it works toward an approval that will give it commercial distribution of Anturol.

Antares said it the FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 8, 2011, 10 months from the official NDA filing, at which time the FDA is expected to complete its review of the NDA, at which time the FDA is expected to complete its review of the NDA.

“The FDA’s acceptance for filing of the NDA for Anturol, Antares Pharma’s first NDA, is another notable achievement for the Company resulting from the dedicated efforts of the entire Antares team. This is an important accomplishment in the continued execution of our product focused strategy,” Paul K. Wotton Ph.D., president and CEO of Antares stated in the press release.

The Anturol NDA submission is supported by data from a 12-week, phase 3 randomized, double-blind, placebo-controlled clinical trial involving 600 patients with OAB. Results demonstrate that patients treated with Anturol daily experienced a significant decrease in OAB symptoms compared to administration of a placebo, including the number of urinary incontinence episodes per day. There were no reported serious treatment-related adverse events.

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