Industry Odisha Bureau, Jun 2: Marking a milestone in the antibiotic innovation ecosystem as well as carving a niche globally, Mumbai-headquartered Indian pharmaceutical and biotechnology company Wockhardt’s innovated ‘Zaynich’ drug has reportedly been accorded seal of approval by the Food and Drug Administration (FDA) of the United States of America (USA).
Notably, “The US FDA is responsible for protecting the public health by ensuring the safety, efficacy and security of human and veterinary drugs.”
Following the remarkable achievement, Wockhardt has reportedly “overcome the scientific risk, while the next challenge is whether this novel drug (Zaynich) developed in India could stand out as a significant commercial success in the global markets or not”.
Reports say that, “Wockhardt’s “Zaynich’ is one of the six novel antibiotics under development by this Indian pharmaceutical and biotechnology company, and all the six novel antibiotics have received ‘Qualified Infectious Disease Product (QIDP)’ and ‘Fast Track’ tags from the US FDA.”
As per media reports, “Zaynich (cefepime + zidebactam) has been accorded the US FDA approval for treating complicated urinary tract infections (UTIs)”.
Media reports added: “Wockhardt plans to launch Zaynich in the US within 6–8 months, and in India within about 5 months. This new-generation antibiotics in the US can cost over $10,000 per treatment, while the cost is expected to be significantly lower in India.”
