1st US FDA-approved drug invented in India set for local launch as part of combination antibiotic

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New Delhi: A molecule developed fully in India, enmetazobactam, which has gone on to become the first-ever internationally approved new drug from the country as part of an antibiotic fixed dose combination (FDC), is set for a local launch...

The combination of enmetazobactam invented by scientists associated with Chennai-based pharma firm Orchid Pharma in 2008 and cefipime, a fourth generation cephalosporin antibiotic, is used in cases of various moderate to severe bacterial infection, and was approved in the US and European Union earlier this year...

The launch of the antibiotic drug combination, Orchid Pharma said, will improve the treatment landscape for serious infections in India, providing patients with access to advanced and effective therapy options...

In this context, Orchid Pharma said the combination drug provides a powerful treatment option against a range of severe infections caused by resistant bacteria, addressing a critical need in combating AMR...

Enmetazobactams approval in India is personally fulfilling as being an Indian company, we wanted to expand access to advanced and affordable treatment options for patients in India, Dhanuka said.. ThePrint had earlier reported that an analysis of data obtained from the Antimicrobial Resistance Surveillance Network (IAMRSN) under the Indian Council of Medical Research (ICMR) had shown that resistance to last-resort antibiotics used for treating bloodstream infections was seeing a significant monthly increase.. First new chemical entity from India ..