Wockhardt Gets US FDA Nod for Novel Antibiotic ZAYNICH

Wockhardt Ltd. announced that the U.S. FDA has approved ZAYNICH™ (cefepime and zidebactam), a novel intravenous antibiotic, for treating adult patients with complicated urinary tract infections (cUTI), including pyelonephritis. ZAYNICH™ demonstrated a higher combined clinical cure and microbiologic response compared to meropenem in the Phase 3 ENHANCE-1 clinical trial (89.0% vs 68.4%). It is the first New Chemical Entity fully developed and commercialized by an Indian pharmaceutical company to receive FDA approval.