Wockhardt gets USFDA QIDP designation for WCK 6777
New Delhi: Drug firm WockhardtNSE 0.09 % 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 the US FDA for approval. The drug is also entitled to a 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.