Drugmaker Wockhardt has received the regulatory green signal from the United States Food and Drug Administration (USFDA) for its Zaynich (cefepime and zidebactam), a novel intravenous antibiotic to treat adults with complicated urinary tract infections (cUTI) – marking a milestone in its research.
Dr Habil F. Khorakiwala, Founder and Chairman of Wockhardt Group said, Zaynich is “the first New Chemical Entity fully developed and commercialized by an Indian pharmaceutical company to receive an FDA approval, representing a historic milestone not only for Wockhardt, but for the Indian pharmaceutical industry.” The drug addresses one of the most urgent global health threats —antimicrobial resistance, he said.
Dennis Deruelle, Wockhardt Chief Medical Officer, further explained, “The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens,” said Dennis Deruelle, Wockhardt Chief Medical Officer, explaining the significance of the approval. The company’s stock price soared on the BSE, up over 11 percent at Rs 2269, on Monday (10.57 am).
Last week, Zaynich was approved by the Drugs Controller General of India (DCGI). Wockhardt has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency, it said.
