U.S. FDA approves Durata's acute bacterial skin infection drug

WASHINGTON Fri May 23, 2014 4:05pm EDT

WASHINGTON May 23 (Reuters) - The U.S. Food and Drug Administration said on Friday it has approved a new drug to treat acute bacterial skin infections made by Durata Therapeutics Inc.

Approval of the drug, Dalvance, follows a positive recommendation by the FDA's advisory committee, which also gave a favorable review to a rival product from Cubist Pharmaceuticals Inc. The FDA is set to rule on the Cubist drug shortly.

Both drugs are designed to treat serious acute bacterial skin and skin structure infections, or ABSSSI. The infections involve deep tissue or are associated with an underlying disease such as diabetes. They are aimed at serious Gram-positive infections, including methicillin-resistant Staphylococcus aureus, or MRSA.

Durata's drug, known generically as dalbavancin, is given in two doses, the first on day one and the second on day eight. (Reporting by Toni Clarke in Washington; Editing by Chizu Nomiyama)

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