Zydus Lifesciences has secured final approval from the US Food and Drug Administration (US FDA) for its corticosteroid drug Jaythari (Deflazacort), a therapeutic option for Duchenne muscular dystrophy (DMD) in patients aged 5 years and above. The approval marks another milestone for Zydus in its US generics portfolio.

Key Highlights

Approval for Rare Disease Treatment

• Jaythari (Deflazacort) is approved for Duchenne muscular dystrophy (DMD), a rare CNS disorder.

• It is a reference listed drug to Emflaza, approved for use in children 5 years and older.

Manufacturing to Be Done in Italy
The drug will be manufactured at Doppel Farmaceutici S.r.l, Zydus’ Italy-based facility.

Strengthening Zydus’ US Portfolio

• With this approval, Zydus has now received 424 ANDA approvals from the US FDA.

• The company has filed a total of 492 ANDAs since FY 2003-04.

Zydus’ FDA approval for Jaythari (Deflazacort) adds another option for managing Duchenne muscular dystrophy, strengthening its presence in the US generics market. This development reflects the company’s continued push into specialized treatments for rare diseases while expanding its global manufacturing footprint.