Zydus Deflazacort Approved by FDA 424 Approvals Achieved
Indian pharmaceutical company Zydus Lifesciences has received final approval from the US Food and Drug Administration (US FDA) for Jaythari (Deflazacort) tablets. The drug is indicated for treating Duchenne Muscular Dystrophy (DMD) in patients 5 years and older, a rare and severe central nervous system disorder.
Deflazacort, a corticosteroid, is a reference-listed equivalent of Emflaza, providing an alternative for managing DMD. The tablets will be manufactured at Zydus’s Italy-based Doppel Farmaceutici facility, ensuring global standards in production.
This milestone brings Zydus’s total US FDA approvals to 424, out of 492 ANDAs filed since 2003-04. The approval signals another step forward for Zydus in addressing rare diseases and expanding its global footprint.
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