FDA approves generic Emflaza oral suspension for the treatment of Duchenne muscular dystrophy

The U.S. Food and Drug Administration has approved the first generic version of the oral suspension Emflaza (deflazacort) for Duchenne muscular dystrophy (DMD). Approval for the generic version of the oral suspension Emflaza was granted to Cranbury Pharmaceuticals (Tris Pharma).

Deflazacort oral suspension is a corticosteroid indicated for the treatment of DMD in patients aged 5 years and older, but is contraindicated in patients with known hypersensitivity to deflazacort. The most commonly reported adverse reactions in patients were Cushing’s syndrome, weight gained, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity and nasopharyngitis.

“Duchenne muscular dystrophy is a devastating rare disease and with limited treatment options available, there is an urgent need for the greater accessibility that a generic therapy can provide,” said Ketan Mehta, founder and CEO of Tris Pharma, in a statement.

“This FDA approval is a significant milestone for patients, caregivers and physicians who may depend on this drug to treat DMD.”

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