Durata Therapeutics announced that the FDA has designated dalbavancin as a Qualified Infectious Disease Product (QIDP) for the treatment of acute bacterial skin and skin structure infections (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) statute, created by Congress to encourage the development of therapies for drug-resistant organisms known to cause serious or life-threatening infections. The GAIN provisions are included in the FDA Safety and Innovation Act (FDASIA) that was signed into law by President Obama in July 2012.
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.
Dalbavancin is a long-acting, intravenous lipoglycopeptide.
For more information call (646) 871-6480 or visit www.duratatherapeutics.com.