Received CDSCO nod for Nafithromycin Antibiotic for CABP, says Wockhardt
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.
Miqnaf is the once-a-day 3-days-only treatment for CABP patients, including those caused by multi-drug resistant (MDR) bugs.
CABP is the most common infection, leading to hospitalisation and death. Globally, 2.4 million annual deaths are caused by lower respiratory tract infections.
India contributes to 23 per cent of the global community pneumonia burden, the drug firm said.
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