Durata Therapeutics, Inc. Announces FDA's Acceptance For Priority Review Of NDA For Dalvance™ (Dalbavancin Hydrochloride)

Published: Nov 27, 2013

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CHICAGO, Nov. 26, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced that the New Drug Application (NDA) for its investigational drug, Dalvance™ (dalbavancin hydrochloride) for injection, has been accepted for priority review by the U.S. Food and Drug Administration (FDA) with an action date of May 26, 2014. Durata is seeking FDA approval of Dalvance™ for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive microorganisms, including MRSA (methicillin resistant Staphylococcus aureus).

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