India Pharma Outlook Team | Friday, 03 October 2025
Wockhardt, a pharmaceutical company based in Mumbai, has received a new drug application (NDA) in the US, Food and Drug Administration (FDA), for its new antibacterial agent, Zidebactam-Cefepime injection (WCK 5222, ZAYNICH).
This is the first time a drug fully discovered, and developed by an Indian pharmaceutical company, has been submitted to the New Drug Application (NDA) at the US Food and Drug Administration (FDA) which is a direct indication of India's enhanced proficiency in pharmaceutical creative breakthroughs.
This new drug application (NDA) aims at getting a green signal for antomical urinary tract infections (cUTI), in which the bacterial infection of the kidney has occurred along with the simultaneous bacteria invasion in the blood caused by Gram-negative bacteria, for example, MDR strains. In the US and EU, more than 8 million cases of cUTI take place every year, which means an urgent call for proper treatments is needed.
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Zidebactam-Cefepime is a first-in-class β-lactam enhancer and β-lactam combination that utilizes a novel mechanism of action to counter the pathogens that resist all other approved antibiotics. Studies in a clinical setting prove that it is very effective against MDR and XDR Gram-negative pathogens, even those that carry NDM carbapenemases and PBP mutations.
This NDA submission is a result of a successful Phase III global clinical trial (ENHANCE 1) which runs 64 sites in India, the U.S., and some European and Asian countries. The FDA has given the designation of a Qualifying Infectious Disease Product (QIDP) and Fast Track to Zidebactam-Cefepime.
