Wockhardt submits US FDA application for Zaynich antibiotic
WOCKPHARMA · price
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Wockhardt submitted a New Drug Application to the US FDA for Zidebactam-Cefepime injection, branded Zaynich, to treat complicated urinary tract infections caused by drug-resistant Gram-negative bacteria. The application follows a global Phase III trial and nine Phase I studies. The drug has Fast Track and Qualified Infectious Disease Product designations, but this is a submission, not approval.
Positive for Wockhardt's innovation pipeline and global growth prospects, but FDA approval and commercial sales remain uncertain, with no immediate financial impact established.