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.
Commenting on the approval, Umang Vohra, Managing Director, and Global CEO, Cipla, said, “The introduction of plazomicin in India is an important step forward in bringing solutions that address the evolving healthcare challenges of our time. Cipla remains steadfast in building capabilities and driving stewardship activities to counter the global threat of AMR. Our focus remains on developing a robust antimicrobial portfolio, forging partnerships with thought leaders and industry alliances to ensure global access to antimicrobial drugs for a healthier life.”
"As a part of Cipla’s extensive efforts to address antimicrobial resistance (AMR), the company is also implementing EHS management programs, strengthening wastewater and solid waste management, adhering to local environmental regulations, and providing vital training towards its sustainability initiatives," the Company added.
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