Durata seeks to GAIN dalbavancin approval

Durata Therapeutics Inc. (NASDAQ:DRTX) submitted an NDA to FDA for dalbavancin to treat acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive bacteria. Dalbavancin, which has Qualified Infectious Disease Product (QIDP) designation from FDA for ABSSSI, is eligible for an additional five years of market exclusivity and automatically receives Priority Review and Fast Track designation under the Generating Antibiotic Incentives Now (GAIN) program. Durata plans to submit an MAA to EMA by year end. ...