India, March 30 -- The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO), has granted a favourable recommendation for marketing permission of Wockhardt's novel antibiotic, Zaynich' (Zidebactam/Cefepime), for the treatment of Gram-negative infections. This positive opinion paves the way for final approval of Zaynich' by the Drugs Controller General of India (DCGI).The recommendation follows a comprehensive review of the product dossier, including non-clinical data, nine Phase 1 studies, a multi-indication Phase 2 study in meropenem-resistant infections, a global Phase 3 study in complicated urinary tract infections and acute pyelonephritis (cUTI/AP), and data from 85 compassionate-use cases.Developed o...