Wockhardt gets CDSCO nod for Zaynich antibiotic

New Delhi, May 28 (PTI) Wockhardt Ltd on Thursday said it has received approval from the Central Drugs Standard Control Organisation (CDSCO) for import and marketing of its indigenously discovered and developed antibiotic, Zaynich (Zidebactam/Cefepime) in India.

The approval is for the treatment of adult patients (18 years and above) with complicated urinary tract infections (cUTI), including pyelonephritis, as well as cases with concurrent Gram-negative bacteremia, Wockhardt Ltd said in a regulatory filing.

The nod by the drug regulator is supported by results from the pivotal ENHANCE-1 study, a multinational, randomised, double-blind Phase 3 clinical trial evaluating the efficacy and safety of Zaynich compared with meropenem in patients with cUTI,

including pyelonephritis, the company said.

In recognition of its broad-spectrum potential, the Clinical and Laboratory Standards Institute has assigned Cefepime/Zidebactam an investigational susceptible breakpoint of 64 mg/L, supporting its potential to cover clinically important extensively drug-resistant (XDR) gram-negative pathogens in critically ill patients, it added. PTI RKL DRR