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Treatment covers ABSSSI
September 27, 2013
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 pre...
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