Market Overview

FDA Designates Durata's Dalbavancin a Qualified Infectious Disease Product

Durata Therapeutics (NASDAQ: DRTX) 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)

See full press release

Posted-In: News Guidance

 

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