Zydus Lifesciences Limited has announced that it has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market its Jaythari® (Deflazacort) tablets in the U.S. The approval includes all four strengths — 6 mg, 18 mg, 30 mg, and 36 mg — which are therapeutic equivalents to Emflaza® Tablets (marketed by the innovator).
Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged five years and above. The approved product will be manufactured at Zydus’ Italy-based facility, Doppel Farmaceutici S.r.l.
With this development, Zydus now has a total of 424 product approvals, having filed 492 Abbreviated New Drug Applications (ANDAs) since the beginning of its U.S. regulatory journey in FY2003–04.
This approval reinforces Zydus’ continuing efforts to expand its footprint in the high-value U.S. generic drug market, particularly in the specialty care segment.
