Wockhardt Gets Coveted Status from U.S. Regulator for Antibiotic Drug
NEW DELHI: A new antibiotic drug by pharmaceutical major Wockhardt has been conferred the status of qualified infectious disease product (QIDP) by the United States Food and Drug Administration (FDA).
The company received the coveted status for the antibiotic named 'WCK 5222', a product from its new drug discovery programme in anti-infectives, Wockhardt said in a filing to the BSE.
"We are pleased that WCK 5222 has received the QIDP status, which is fourth for the company in quick succession," said Wockhardt chairman Habil Khorakiwala.
"The company's relentless focus for almost two decades in the anti infective space has started showing recognition with consecutive approvals for QIDP in quick succession," Mr Khorakiwala added.
WCK 5222 is a new class of antibiotic for "gram negative terrain" for complicated urinary tract infections and hospital acquired bacterial pneumonia, the company added.
Mr Khorakiwala claimed that when 5222 is approved, it will save many lives worldwide.
He added there was a global crisis of availability of antibiotics to fight resistant bacteria and there had been a huge void in anti infectives as relatively very few drugs had been discovered in the past decade.
The QIDP status is granted to drugs identified by Centre for Disease Control, U.S, 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 US health regulator for drug approval and a five-year extension of market exclusivity after product approval in the U.S.
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