Durata Therapeutics' NDA For Dalvance Accepted For Priority Review By FDA

(RTTNews) - Durata Therapeutics, Inc. (DRTX) Tuesday said its New Drug Application for Dalvance has been accepted for a priority review by the U.S Food and Drug Administration.

Dalvance, or dalbavancin hydrochloride, for injection is a second generation, lipoglycopeptide, indicated for treating acute bacterial skin and skin structure infections caused by susceptible Gram-positive microorganisms.

The NDA, submitted on September 26, was based on the entire data set from Durata Therapeutics' clinical development program, including results from two Phase 3 trials DISCOVER 1 and DISCOVER 2, as well as a previous Phase 3 study.