Wockhardt’s NDA for Zaynich gets accepted by USFDA

01 Dec 2025 Evaluate

The United States Food and Drug Administration (USFDA) has formally accepted Wockhardt’s New Drug Application (NDA) for its novel, first-in-class antibiotic Zaynich. The NDA was originally filed on September 30, 2025, and its acceptance marks a transformative moment for the entire Indian pharmaceutical industry. This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA.

Zaynich has been granted Fast Track designation by the USFDA, recognizing its potential to address urgent and unmet medical needs. As part of this pathway, the FDA has committed to assign priority to Zaynich NDA review. A novel β-lactam enhancer mechanism based Zaynich has garnered international attention for its potent activity against highly resistant Gram-negative pathogens - microbes responsible for prolonged hospitalizations and significant mortality worldwide. Its life-saving impact has already been demonstrated through compassionate use in critically ill patients in both India and the United States.

Wockhardt is a research based Global Pharmaceutical and Biotech company.

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