Indian drugmaker Cipla Limited (BSE: 500087) says it has received approval from the Central Drugs Standard Control Organization (CDSCO) to market the novel antibiotic Zemdri (plazomicin) in India.
Cipla acquired plazomicin, developed by US firm Achaogen, in 2019, in a Chapter 11, US Bankruptcy Code auction of Achaogen’s assets.
Plazomicin is a new intravenous (IV) aminoglycoside indicated for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis. UTIs are a global health problem affecting around 150 million patients each year. The emergence of drug resistant uropathogens has posed a big challenge in management of UTIs. A pivotal clinical trial and in-vitro studies demonstrated efficacious and safe results in comparison to meropenem. It also highlighted plazomicin’s ability to retain in-vitro activity against strains resistant to older aminoglycosides.
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