USFDA New Drug Antibiotic Regulatory team agrees to abridge clinical trial for Phase III clinical trial
Wockhardt announced that in a recent meeting between Wockhardt Research team and USFDA New Drug Antibiotic Regulatory team, USFDA agreed to abridge clinical trial for Phase III for Wockhardt's super drug antibiotic WCK 5222. This was based on the clinical evalutation by USFDA of its preclinical and clinical data of Phase I establishing safety and clinical scope of efficacy for the drug. WCK 5222 contains Zidebactam coming out of Wockhardt's Drug Discovery team of 140 strong scientists working for antibiotics research since last 20 years.WCK 522 is a combination of Zidebactam and Cefepime. This superdrug introduces an entire new class of antibiotic treatment. It is expected to be a life-saving destination therapy for serious hospital acquired infections such as pneumonia, ventilator associated pneumonia, blood stream infections.
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