India, Dec. 1 -- Wockhardt 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, and its acceptance marks a transformative moment'not only for Wockhardt, but also 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 US FDA.Zaynich has been granted Fast Track designation by the US FDA, recognizing its potential to address urgent and unmet medical needs. As part of this pathway, the FDA has committed to assign priority to Zaynich N...