Zaynich's U.S. FDA Approval Marks Breakthrough For Indian Pharma

Wockhardt has received US FDA approval for Zaynich (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adults with complicated urinary tract infections, including pyelonephritis. The approval follows positive results from the Phase 3 ENHANCE-1 study, where Zaynich demonstrated superior efficacy to meropenem. Wockhardt said Zaynich is the first new chemical entity fully developed and commercialised by an Indian pharmaceutical company to receive U.S. FDA approval. The company recently secured approval for the antibiotic in India and has also submitted a marketing authorisation application in Europe.