New Launch3 Jan 2025, 12:45 am
Indian Drug Regulator Approves Wockhardt's New Generation Oral Antibiotic MiqnafR (Nafithromycin) for CABP Treatment
AI Summary
The Indian drug regulator, Central Drugs Standard Control Organization (CDSCO), has approved Mignaf® (nafithromycin) as a new treatment for the Community-Acquired Bacterial Pneumonia (CABP) in Adults. Mignaf® is an ultra-short course, once-a-day, 3-day treatment for CABP including those caused by multi-drug resistant (MDR) pathogens. The approval follows a favourable recommendation for manufacture and marketing of Nafithromycin from the Subject Expert Committee (SEC) of CDSCO. Mignaf® represents a new macrolide based treatment for CABP in India almost after a gap of 30 years. Wockhardt plans to launch Mignaf® in the Indian market in coming few months.
Key Highlights
- Indian Drug Regulator approves Wockhardt's new generation oral antibiotic MiqnafR (Nafithromycin) for CABP treatment
- Mignaf® is an ultra-short course, once-a-day, 3-day treatment for CABP including those caused by multi-drug resistant (MDR) pathogens
- Mignaf® represents a new macrolide based treatment for CABP in India after a gap of 30 years
- Mignaf® covers entire range of community respiratory pathogens including pneumococci resistant to azithromycin and amoxicillin/clavulanate
- Wockhardt plans to launch Mignaf® in the Indian market in coming few months