Priority Review for Durata's dalbavancin
FDA accepted and granted Priority Review to an NDA from Durata Therapeutics Inc. (NASDAQ:DRTX) for Dalvance dalbavancin ( RQ-00000002) to treat acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive bacteria. The PDUFA date is May 26, 2014. Dalbavancin has Qualified Infectious Disease Product (QIDP) designation from FDA for the indication and is eligible for an additional five years of market exclusivity under the Generating Antibiotic Incentives Now (GAIN) program.
Durata plans to submit an MAA for dalbavancin to EMA by year end. The company gained the second-generation once-weekly glycopeptide antibiotic through its 2009 acquisition of Vicuron Pharmaceuticals Inc., which was a subsidiary of Pfizer Inc. (NYSE:PFE). ...