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.