US FDA Accepts Wockhardt’s New Drug Application for Zaynich
Filing Summary
Wockhardt Ltd. has announced that the United States Food and Drug Administration (US FDA) has accepted its New Drug Application (NDA) for the antibiotic Zaynich. This marks the first acceptance of an NDA for a New Chemical Entity from an Indian pharmaceutical company by the US FDA. The NDA was filed on September 30, 2025. Zaynich has been granted Fast Track designation, which prioritizes its review due to its potential to address urgent medical needs. The acceptance represents a significant milestone for Wockhardt and the Indian pharmaceutical industry.
On December 1, 2025, Wockhardt Ltd. announced that the United States Food and Drug Administration (US FDA) has accepted its New Drug Application (NDA) for the antibiotic Zaynich. The NDA was initially filed on September 30, 2025. This acceptance is a significant milestone as it is the first time an NDA for a New Chemical Entity from an Indian pharmaceutical company has been accepted by the US FDA.
The submission of an NDA to the US FDA involves meeting stringent scientific and regulatory standards. It requires comprehensive clinical evidence, advanced manufacturing capabilities, and adherence to rigorous compliance across various domains. The acceptance of Wockhardt’s NDA highlights the company’s scientific capabilities and development excellence.
Zaynich has been granted Fast Track designation by the US FDA, which acknowledges its potential to address urgent and unmet medical needs. This designation ensures that the FDA will prioritize the review of the Zaynich NDA. The drug is noted for its novel β-lactam enhancer mechanism, which has shown potent activity against highly resistant Gram-negative pathogens. These pathogens are responsible for prolonged hospitalizations and significant mortality worldwide.
Over the past decade, Zaynich has been extensively studied, reflecting a comprehensive development program initiated by Wockhardt in 2011. The company has successfully navigated the demanding non-clinical, clinical, and regulatory pathways necessary for the drug’s development.
Wockhardt is a global pharmaceutical and biotechnology company focused on developing innovative anti-infective solutions. The company is committed to combating antimicrobial resistance and continues to pioneer next-generation therapies aimed at addressing serious threats in global healthcare.