Dalvance dalbavancin regulatory update

FDA approved Durata's Dalvance dalbavancin to treat acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). The agency said Dalvance is the first drug with Qualified Infectious Disease Product (QIDP) designation to receive FDA approval. The designation qualifies Dalvance for an additional 5 years of market exclusivity. Durata said it expects to launch Dalvance in the U.S. next quarter, but the company has not yet set a price. ...