ZYDUSLIFE Receives USFDA Nod for Jaythari (Deflazacort) for DMD Treatment

Published • 12 April 2025 at 5:56 AM

USFDA approves Zydus’s Jaythari tablets in multiple strengths for DMD therapy — Zydus Lifesciences receives USFDA approval for Jaythari tablets to treat Duchenne DMD

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Zydus Lifesciences Ltd (NSE: ZYDUSLIFE) has received final approval from the USFDA for its Jaythari (Deflazacort) Tablets in 6 mg, 18 mg, 30 mg, and 36 mg strengths. Jaythari is the generic version of Emflaza, used for treating Duchenne muscular dystrophy (DMD), a rare genetic disorder causing progressive muscle weakness. The drug is approved for use in patients aged 5 years and older. Jaythari will be manufactured at Doppel Farmaceutici S.r.l. in Italy, adhering to global quality standards. This approval enhances Zydus’s presence in the U.S. generics market and reflects its ongoing commitment to affordable healthcare. With Jaythari, Zydus now holds 424 USFDA approvals and has filed 492 ANDAs since FY 2003-04. Additionally, Zydus recently incorporated Zydus MedTech (France) SAS and is set to acquire 85.6% equity in Amplitude Surgical for €256.8 million. The move expands Zydus’s global footprint and medtech portfolio, aligning with its growth and innovation strategy.

Key Highlights

USFDA Approval: Zydus Lifesciences received final approval from the USFDA for its Jaythari (Deflazacort) Tablets.
Dosage Strengths: Approved in 6 mg, 18 mg, 30 mg, and 36 mg strengths.
Generic Launch: Jaythari is the generic version of Emflaza, used to treat Duchenne muscular dystrophy (DMD).
Indication: Approved for use in patients aged 5 years and older.
Manufacturing Location: Jaythari will be manufactured at Doppel Farmaceutici S.r.l. in Italy.
Market Impact: Strengthens Zydus's position in the U.S. generics market.
Regulatory Milestone: Zydus now holds 424 USFDA approvals and has filed 492 ANDAs since FY 2003-04.
Global Expansion: Incorporated Zydus MedTech (France) SAS as a wholly owned subsidiary.
Strategic Acquisition: Set to acquire 85.6% stake in Amplitude Surgical for €256.8 million.
Growth Strategy: The approval and acquisition align with Zydus’s focus on global growth and innovation in medtech.