Wockhardt share price jumps 27% in 2 days after US FDA accepts new drug application for breakthrough antibiotic Zaynich

Key Highlights

• “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,” Wockhardt said in its regulatory update.
• This acceptance marks a major breakthrough not only for Wockhardt but for the entire Indian pharmaceutical industry, positioning India on the global innovation map.
• Zaynich is a combination therapy made up of Zidebactam, a β-lactam enhancer, and Cefepime, a fourth-generation cephalosporin.
• The drug is designed to address life-threatening multi-drug resistant (MDR) and extensively drug-resistant (XDR) bacterial infections, including high-risk pathogens such as Pseudomonas Aeruginosa, Acinetobacter Baumannii, and Carbapenem-resistant strains.
• The company noted that Zaynich has already been granted Fast Track designation by the US FDA, underscoring its potential to meet urgent unmet medical needs.