Wockhardt New Drug Application for Breakthrough antibiotic Zaynich accepted by USFDA
Mumbai: Wockhardt Ltd. has announced that the United States Food and Drug Administration (US FDA) has formally accepted the New Drug Application (NDA) for its novel, first-in-class antibiotic Zaynich.
The NDA was originally filed on September 30, 2025.
As per the company, 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 US FDA.
Zaynich has been granted Fast Track designation by the US FDA. 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.
Over the past decade, Zaynich has become one of the most extensively studied antibiotics globally, reflecting a comprehensive, science-driven development program initiated by Wockhardt in 2011. The company has successfully navigated a demanding non-clinical, clinical and regulatory pathway.
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Commenting on the milestone, Wockhardt stated, “The FDA’s acceptance of the Zaynich NDA is a historic and proud moment for the organization and for India. It reaffirms our commitment to developing advanced anti-infective solutions for the world and demonstrates what Indian science and innovation can achieve on the global stage.”
Wockhardt is a global pharmaceutical and biotechnology company focused on developing innovative antiinfective solutions.
