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  • Received CDSCO nod for...

Received CDSCO nod for Nafithromycin Antibiotic for CABP, says Wockhardt

Written By : Meghna A Singhania Published On 2024-10-14T13:21:36+05:30  |  Updated On 14 Oct 2024 1:21 PM IST
Received CDSCO nod for Nafithromycin Antibiotic for CABP, says Wockhardt
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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.
Read also: Wockhardt group Founder Chairman Dr Habil Khorakiwala bags Lifetime Achievement Award at 10th IHW summit in Dubai
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.
Read also: CDSCO Panel Approves Wockhardt's Protocol Amendment Proposal for antimicrobial drug Cefepime plus Zidebactam
WockhardtCABPSubject Expert CommitteeCentral Drugs Standard Control OrganisationMiqnafDCGIMDR
Meghna A Singhania
Meghna A Singhania

Meghna A Singhania is the founder and Editor-in-Chief at Medical Dialogues. An Economics graduate from Delhi University and a post graduate from London School of Economics and Political Science, her key research interest lies in health economics, and policy making in health and medical sector in the country. She is a member of the Association of Healthcare Journalists. She can be contacted at meghna@medicaldialogues.in. Contact no. 011-43720751

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