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FIRST QUALIFIED INFECTIOUS DISEASE PRODUCT

Durata's Dalvance clears FDA at last, gains approval in bacterial skin infections

By Jennifer Boggs
Managing Editor

Tuesday, May 27, 2014
Just ahead of the three-day weekend, the FDA granted approval of antibiotic dalbavancin, a drug that ended its long and winding development road by becoming the first qualified infectious disease product (QIDP) to win approval, getting the nod for use in acute bacterial skin and skin structure infections (ABSSSIs) caused by gram-positive microorganisms, including the dreaded methicillin-resistant Staphylococcus aureus.

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