Cipla gets CDSCO nod to market novel antibiotic Plazomicin in India, to launch under brand name Zemdri
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-03-05 06:41 GMT | Update On 2024-03-20 10:56 GMT
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Mumbai: Cipla Limited has received approval from the Central Drugs Standard Control Organization (CDSCO) to market the novel antibiotic plazomicin in India.
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 approximately 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.
"Plazomicin's introduction in India underscores Cipla's proactive response to the urgent global challenge of antimicrobial resistance (AMR)," the company stated.
Cipla USA, a subsidiary of Cipla, holds the patent for plazomicin sulfate, an intravenous aminoglycoside administered once daily. The company possesses global rights for this molecule, excluding Greater China, and is the innovator of the brand called ZEMDRI. Cipla USA currently markets the product in the USA, where it received approval from the US FDA in 2018. ZEMDRI, for an appropriate time, held the designation of a new technology add-on payment (NTAP) status granted by the US Medicare and Medicaid Services (CMS) - specifically for hospital administration.
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