Zydus Lifesciences Ltd has received final approval from the US Food and Drug Administration for its Deflazacort oral suspension, marking a key milestone in its North American expansion strategy.
Key Highlights:
- Deflazacort is used to treat Duchenne muscular dystrophy, a rare genetic disorder
- Approval covers 22.75 mg per 5 mL formulation, enhancing patient compliance through liquid dosage
- Product to be manufactured at Zydus’s Ahmedabad facility under stringent USFDA norms
- Launch expected in Q4 FY2025–26, targeting both institutional and retail channels
- Adds to Zydus’s growing portfolio of complex generics and specialty therapies in the US
- Company aims to strengthen its rare disease pipeline and global regulatory footprint
Sources: Zydus Lifesciences Regulatory Filing, USFDA Approvals Database, Business Standard Pharma Desk 2025