Wockhardt gets QIDP designation from USFDA for its combination antibiotic

Drug firm Wockhardt on Monday said it has received Qualified Infectious Disease Product (QIDP) designation from the US health regulator for its combination antibiotic, WCK 6777.

The QIDP status is granted to drugs that are effective against a set of multi-drug resistant pathogens identified by the Centre for Disease Control, USA, which have a high degree of unmet need in the treatment of patients infected by such pathogens, Wockhardt said in a filing to the BSE.

The status provides fast track clinical development and review of the drug application by US FDA for approval. The drug is also entitled for five-year extension of market exclusivity, it added.

The company has received QIDP designation from the United States Food and Drug Administration (USFDA) for WCK 6777, a once-a-day combination antibiotic, it added.

The drug for injection has been awarded QIDP for the treatment of complicated urinary tract infections, including pyelonephritis and treatment of complicated intra-abdominal infections, Wockhardt said.

"Wockhardt has planned for the global development of WCK 6777 covering important markets of the US, Europe, China and India," Wockhardt Group Founder Chairman Habil Khorakiwala said.

Shares of Wockhardt were trading at Rs 267 per scrip on the BSE, down 1.37 per cent from its previous close.