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Durata Therapeutics Inc Announces NDA Submission for Dalbavancin for Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections


Thursday, 26 Sep 2013 02:48pm EDT 

Durata Therapeutics Inc announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of dalbavancin 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 submission is based on the entire data set from Durata Therapeutics' clinical development program, including positive results from two Phase 3 trials DISCOVER 1 and DISCOVER 2, as well as a previous Phase 3 study (VER-009). Both DISCOVER 1 and DISCOVER 2 trials were conducted under a Special Protocol Assessment (SPA) with the FDA. In November 2012, the FDA designated dalbavancin as a Qualified Infectious Disease Product (QIDP). The QIDP provides Durata Therapeutics priority review by the FDA, eligibility for fast-track status, and extension of statutory exclusivity periods for an additional five years upon FDA approval of the product. 

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17 Sep 2014