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One More On QIDP List – Does It Help Wockhardt?

Regulatory Overhang An Impediment

 
• By Vibha Ravi

Wockhardt has received QIDP designation in the US for its once-daily zidebactam-based combination antibiotic WCK 6777, taking to six its portfolio products with the status. But unless the FDA gives a clean sheet to the company’s major manufacturing units, this won't help US revenues 

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Will QIDP Status For Novel Antibiotic Help Wockhardt's US Revenues? • Source: Shutterstock

India's Wockhardt Ltd. has received qualified infectious disease product (QIDP) status from the US Food and Drug Administration (FDA) for its zidebactam-based combination antibiotic WCK 6777 to treat complicated urinary tract infections and complicated intra-abdominal infections, taking to six the total number of its products with this special designation.

The agency grants QIDP status to drugs effective against a set of multi-drug resistant pathogens identified by the Centers for Disease Control, providing an incentive to companies for the development of antibacterial and antifungal drugs for serious and life-threatening

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