Wockhardt files NDA for novel antibiotic against drug-resistant infections
Wockhardt announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Zidebactam-Cefepime (WCK 5222, ZAYNICH™). This injection is for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, with or without concurrent bacteremia caused by Gram-negative bacteria. This marks the first-ever NDA submission to the U.S. FDA for a drug fully discovered and developed by an Indian pharmaceutical company.
Zidebactam-Cefepime is a first-in-class β-lactam enhancer and β-lactam combination, targeting multi-drug resistant (MDR) and extreme drug resistant (XDR) Gram-negative pathogens. The NDA submission follows a pivotal Phase III global clinical trial (ENHANCE 1) conducted across 64 sites. The drug has also received Qualified Infectious Disease Product (QIDP) and Fast Track Designation from the US FDA.
Wockhardt has been at the forefront of antibiotic innovation for over 27 years, with a pipeline of six antibiotics in various stages of clinical development, all of which have been granted QIDP designation by the US FDA. The company employs approximately 2,900 people across 27 nationalities and generates about 77% of its global revenues from international businesses.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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