Wockhardt Submits New Drug Application to U.S. FDA for Zidebactam-Cefepime (WCK 5222) for Treatment of Serious Gram-Negative Infections

Wockhardt, a research-based global pharmaceutical and biotech company, announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (US FDA) for its novel antibacterial agent Zidebactam-Cefepime injection (WCK 5222, ZAYNICH™). The NDA seeks approval for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, with or without concurrent bacteremia caused by Gram-negative bacteria including multidrug-resistant (MDR). This is a significant achievement as it is the first-ever NDA submission to the U.S. FDA for a drug fully discovered and developed by an Indian pharmaceutical company. The drug represents a first-in-class B-lactam enhancer and PB-lactam combination, introducing a novel mechanism of action to combat some of the most difficult-to-treat infections.