Received CDSCO nod for Nafithromycin Antibiotic for CABP, says Wockhardt
Written By : Meghna A Singhania
Published On 2024-10-14 07:51 GMT | Update On 2024-10-14 07:51 GMT
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New Delhi: Pharmaceutical company Wockhardt has announced that it has received a positive recommendation from the national drug regulator for its antibiotic, developed to treat 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.
A positive opinion from the SEC of CDSCO would pave the way for gaining DCGI's final approval for Miqnaf, the company stated.
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