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Home » FDA Agrees to Abridged Phase III Trial for Wockhardt Antibiotic
FDA Agrees to Abridged Phase III Trial for Wockhardt Antibiotic
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The FDA agreed to an abridged Phase III clinical trial for Wockhardt’s antibiotic WCK 5222.
This was based on evaluation of its preclinical and clinical data of a Phase I trial establishing safety and clinical scope of efficacy for the drug.
WCK 5222 is a combination of cefepime and zidebactam, a new drug developed by Wockhardt.
The FDA previously granted a fast track and a qualified infectious disease product designation for the drug. Wockhardt expects a global clinical launch of WCK 5222 during the year 2020-21.
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