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Trials & Filings

Durata Files NDA for Dalbavancin

Treatment covers ABSSSI

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Durata Therapeutics has submitted an NDA to the FDA seeking approval for 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 III trials DISCOVER 1 and DISCOVER 2, as well as a previous Phase III 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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