Dalbavancin regulatory update

FDA accepted and granted Priority Review to an NDA from Durata for Dalvance dalbavancin to treat acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive bacteria. The PDUFA date is May 26. Dalbavancin has Qualified Infectious Disease Product (QIDP) designation from FDA for the indication and is eligible for an additional 5 years of market exclusivity under the Generating Antibiotic Incentives Now (GAIN) program (see BioCentury, Nov. 12, 2012). ...