Home Industry Pharmaceuticals and Life Sciences Zydus Lifesciences Wins USFDA ...

Zydus Lifesciences Wins USFDA Approval for DMD Drug


Pharmaceuticals and Life Sciences

Zydus Lifesciences Secures USFDA Nod for DMD Treatment Drug

Zydus establishes Zydus MedTech France as part of its Amplitude Surgical acquisition and obtains USFDA approval to market Jaythari for Duchenne muscular dystrophy.

The USFDA approved Zydus Lifesciences for the production of Jaythari (Deflazacort) tablets in four strengths such as 6 mg, 18 mg, 30 mg, and 36 mg.

It is the generic equivalent of Emflaza tablets and is prescribed to patients with Duchenne muscular dystrophy (DMD) aged five and up. Jaythari will be manufactured by the Italian plant of Doppel Farmaceutici S.r.l.

After receiving this one, Zydus now has 424 final ANDA (Abbreviated New Drug Application) approvals from the USFDA. Since the corporation started the process in FY 2003-04, it has submitted 492 ANDAs.

Separately, Zydus Lifesciences revealed that Zydus MedTech (France) SAS, its Indian company, has been incorporated as a wholly owned subsidiary in France. The action is a calculated step in Zyduss's continuous purchase of the French medical device manufacturer Amplitude Surgical SA.

This comes after Zydus announced on March 11, 2025, that it had agreed to pay 256.8 million euros in consideration for a block acquisition of an 85.6% controlling interest in 6.25 euros per share for Amplitude Surgical SA.

Zydus plans to initiate a required cash tender offer for the remaining Amplitude Surgical shares at the same price following the successful completion of this block transaction. The corporation intends to proceed with a squeeze-out of minority shareholders and then delist the target entity if certain conditions are met.


Business News


Recommended News

Latest Magazine