Wockhardt receives US FDA's drug discovery status for new antibiotic

The US Food and Drug Administration (FDA) has granted Wockhardt’s WCK 5222, a product from its breakthrough new drug discovery program in anti-infectives, Qualified Infectious Disease Product (QIDP) status. This is the fourth product from Wockhardt to receive this coveted status. During last year, Wockhardt received approval for WCK 771 & WCK 2349 and in early this year approval was received for WCK 4873. The only company globally to receive QIDP status for four drugs from US FDA.
 
QIDP status is granted to drugs, identified by CDC (Centre for Disease Control, USA), that act against pathogens which have a high degree of unmet need in their treatment. QIDP status provides fast track clinical development and review of the drug application by US FDA for drug approval and a five-year extension of market exclusivity post product approval in the USA. QIDP was constituted under Generating Antibiotic Incentives Now (GAIN) Act in 2012 as part of the FDA Safety and Innovation Act to underline the urgency in new antibiotics development.