FDA accepts priority review of Durata NDA for Dalvance

27 November 2013

Shares of Durata Therapeutics (Nasdaq: DRTX) leapt 13.4%, following the news that the New Drug Application for its investigational drug Dalvance (dalbavancin hydrochloride) has been accepted for priority review by the US Food and Drug Administration.

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). The FDA has set a Prescription Drug User Fee (PDUFA) action date of May 26, 2014 for the review.

Competitor for Cubicin?

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