Wockhardt's Zaynich antibiotic accepted by US FDA

Wockhardt Ltd. today announced that the US FDA has formally accepted the New Drug Application (NDA) for Zaynich, a novel, first-in-class antibiotic. This marks the first time an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the US FDA. The NDA was originally filed on September 30, 2025.

Zaynich has been granted Fast Track designation by the US FDA, acknowledging its potential to address urgent medical needs and committing to priority review. The antibiotic, developed by Wockhardt since 2011, is designed to combat highly resistant Gram-negative pathogens and has shown life-saving impact through compassionate use in critically ill patients in both India and the United States.

Wockhardt emphasized that the FDA's acceptance reaffirms its commitment to developing advanced anti-infective solutions and showcases Indian science and innovation on a global scale. This achievement highlights the company's scientific depth, innovation strength, and global-standard development excellence.