Wockhardt gets favourable recommendation from CDSCO for antibiotic for CABP

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The story "Wockhardt gets favourable recommendation from CDSCO for antibiotic for CABP" was covered 8 hours ago by Business Standard, a news publisher based in India.

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Wockhardt gets favourable recommendation from CDSCO for antibiotic for CABP - Business Standard

Quick Summary:

Drug firm Wockhardt on Friday said the national drug regulator has accorded a favourable recommendation for its novel antibiotic developed for the treatment of community-acquired bacterial pneumonia (CABP) in adults.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has provided a favourable recommendation for Miqnaf (nafithromycin), the drug firm said in a statement.

The SEC recommendation is based on CDSCO's comprehensive review of the product dossier consisting of non-clinical, US/EU Phase 1, Global Phase 2 and India Phase 3 clinical studies conducted over the last 15 years, it added.