Wockhardt’s antibiotic Miqnaf recommended by CDSCO
Indian drugmaker Wockhardt’s (BSE: 532300) today announced that the Subject Expert Committee (SEC) of Indian drug regulator, Central Drugs Standard Control Organization (CDSCO) has provided a favorable recommendation for its novel antibiotic Miqnaf (nafithromycin) discovered and developed for the treatment of community-acquired bacterial pneumonia (CABP) in adults.
Wockhardt, whose shares rose 5% to 1,046.55 rupees on the news, said that the SEC recommendation is based on CDSCO’s comprehensive review of product dossier consisting of non-clinical, US/EU Phase I, Global Phase II and India Phase III clinical studies conducted over the last 15 years. A positive opinion from SEC of CDSCO would pave the way for gaining DCGI’s final approval for Miqnaf.
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