Zydus Lifesciences Receives FDA Approval for Deflazacort to Treat DMD

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Zydus Lifesciences Ltd received final FDA approval for Deflazacort oral suspension, 22.75 mg/mL, indicated for Duchenne Muscular Dystrophy treatment, as of October 6, 2025.

On Monday, October 6, pharmaceutical company Zydus Lifesciences announced that the FDA has given its final approval for its oral suspension of deflazacort at a dose of 22.75 mg/mL. The product contains 22.75 mg/mL of Emflaza oral suspension in a generic form.

What is Deflazacort (Emflaza)?

Patients five years of age and older with Duchenne Muscular Dystrophy (DMD) may be treated with deflazacort oral suspension. As a member of the steroid class, the medication helps reduce inflammation and quiet down an overreactive immune system.

The product will be produced in Doppel, Italy, according to Zydus. This approval brings the group’s overall number of approvals to 424.

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Disclaimer: This article is for informational purposes only and does not provide medical advice. Patients and families should discuss treatment options and clinical trials with their healthcare professionals.

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