The US Food and Drug Administration (FDA) has accepted the new‑drug application (NDA) filed by Wockhardt Ltd. for its novel antibiotic Zaynich, marking a significant milestone for Indian pharmaceutical innovation.
Zaynich, a combination of the antibiotic Cefepime and the beta-lactamase inhibitor/enhancer Zidebactam — is designed to tackle serious multidrug‑resistant Gram‑negative infections, including complicated urinary tract infections (cUTIs).
The drug earlier demonstrated strong results in global clinical trials, where it showed over 96.8% efficacy in Phase III studies, a benchmark which analysts regard as among the highest for novel antibiotics in recent years.
Following the FDA’s acceptance of the NDA, shares of Wockhardt soared, rising more than 11% on the Bombay Stock Exchange, reflecting investor optimism and heightened market interest in the company’s antibiotic development portfolio.
With this regulatory milestone, Zaynich is positioned to enter a global market that is increasingly demanding effective therapies against antibiotic‑resistant infections.
Wockhardt’s development could also signal a revival of antibiotic innovation in India, given the decades‑long drought of new breakthrough drugs combating resistant Gram-negative pathogens.
