Zydus gains USFDA approval for deflazacort oral suspension

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Deflazacort oral suspension, 22.75 mg/mL. This medication is indicated for treating Duchenne Muscular Dystrophy (DMD) in patients aged five years and older, working to decrease inflammation and regulate the immune system. The oral suspension will be produced at Doppel, Italy.

This approval contributes to the group's growing portfolio, bringing its total number of approvals to 424. Zydus has filed 487 Abbreviated New Drug Applications (ANDAs) since initiating its filing process in fiscal year 2003-04, as of September 30, 2025.