Zydus Gets USFDA Nod for Jaythari Tablets

16 Apr 2025 , 10:54 AM

Zydus Lifesciences Ltd in its press release dated April 11, 2025, stated that it has received US Food and Drug Administration (USFDA) final approval for its Emflaza Tablets generic drug marketed as Jaythari (Deflazacort) Tablets. The approval includes various strengths of Jaythari, 6 mg, 18 mg, 30 mg, and 36 mg, which adds to Zydus’ portfolio of products in the US generic pharma market.

Jaythari is indicated for the treatment of Duchenne Muscular Dystrophy (DMD), a rare and genetic disease that results in ongoing muscle weakness and degeneration. The drug is intended for use in patients 5 years and above. Production of Jaythari will be conducted at Doppel Farmaceutici S.r.l. in Italy, adhering to strict global quality and regulatory requirements.

Zydus Lifesciences explained that the said approval comes within its mandate to make such treatment more widely accessible and affordable, particularly in respect of rare and life-altering diseases.

With this milestone, Zydus now boasts a cumulative figure of 424 final USFDA approvals that testifies to the company’s firm regulatory competences and persistent intent on innovations across the generic area.

Since starting its Abbreviated New Drug Application (ANDA) filings in FY 2003-04, the company has submitted 492 ANDAs as of March 31, 2025, registering its sustained momentum in the US generics space. In another development, Zydus also announced the incorporation of its wholly owned subsidiary — Zydus MedTech (France) SAS — in France, widening its global presence.

This action follows Zydus Lifesciences’ earlier announced deal on March 11, 2025, to buy 85.6% holding in Amplitude Surgical, a French medical devices company, at €6.25 per share for a total transaction value of €256.8 million. The deal is anticipated to further bolster Zydus’ position in the European medtech market, supporting its plans to diversify by therapeutic segments and geographies.