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  • Wockhardt gets USFDA...

Wockhardt gets USFDA QIDP designation for WCK 6777

Ruchika SharmaWritten by Ruchika Sharma Published On 2020-04-22T12:42:25+05:30  |  Updated On 22 April 2020 12:42 PM IST
Wockhardt gets USFDA QIDP designation for WCK 6777
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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.

Read also: Wockhardt Sells Baddi Plant, 62 Drug Brands To Dr Reddys For Rs 1850 Crore

wockhardtqidpusfdawck-6777
Source : PTI
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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