FDA Designates Durata's Dalbavancin a Qualified Infectious Disease Product

Durata Therapeutics

today announced that the U.S. Food and Drug Administration (FDA) has designated dalbavancin as a Qualified Infectious Disease Product (QIDP). The QIDP designation provides Durata priority review by the FDA, eligibility for fast-track status, and extension of statutory exclusivity periods for an additional five years upon FDA approval of the product for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Dalbavancin is Durata's lead product candidate, currently under investigation for the treatment of ABSSSI caused by susceptible Gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus). Dalbavancin is among the first anti-infective agents to receive QIDP designation through the new Generating Antibiotic Incentives Now (GAIN)