USFDA grants breakthrough drug discovery status to Wockhardt's antibiotic drug

BT Online   New Delhi     Last Updated: December 8, 2015  | 16:31 IST
USFDA grants breakthrough drug discovery status to Wockhardt's antibiotic drug
Wockhardt is the only company globally whose four products achieved this status from USFDA in quick succession. Photo: Reuters

Drug major Wockhardt announced on Tuesday that US Food and Drug Administration (USFDA) has granted breakthrough qualified infectious disease product (QIDP) drug discovery status to the new antibiotic product of the company.

WCK 5222, an antibiotic from new drug discovery in anti defectives, is the fourth product from the drug firm to receive this coveted status. Wockhardt is the only company globally whose four products achieved this status from USFDA in quick succession.

"WCK 5222 is a new class of antibiotic for gram negative terrain for complicated Urinary Tract Infections and Hospital-acquired bacterial pneumonia (HABP)," said Dr Habil Khorakiwala, Chairman, Wockhardt.

"There is a global crisis of availability of antibiotics to fight resistant bacteria and there has been a big void in Anti Infective as relatively very few drugs have been discovered in the last decade," Khorakiwala added.

QIDP status is granted to drugs identified by Centre for Disease Control, US, that act against pathogens which have a high degree of unmet need in their treatment.

The status provides fast track clinical development and review of the drug application by the USFDA for drug approval and a five year extension of market exclusivity post product approval in the US.

Wockhardt stock closed the day at Rs 1,637.25, down 0.87 per cent, on the BSE.

 


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