RARE Daily

Cranbury Pharmaceuticals Receives FDA Approves Cranbury’s Generic Version of Emflaza for DMD

June 12, 2024

Rare Daily Staff

The U.S. Food and Drug Administration approved Tris Pharma subsidiary Cranbury Pharmaceuticals’ Abbreviated New Drug Application for the first generic version of Emflaza oral suspension  for the treatment of Duchenne muscular dystrophy.

Deflazacort oral suspension is indicated to treat DMD in patients five years of age and older. DMD is a rare genetic disorder characterized by progressive muscle degeneration and weakness. The disease primarily affects boys, with symptom onset in early childhood.

“Duchenne muscular dystrophy is a devastating rare disease, and with limited treatment options available there is a critical need for the greater accessibility that a generic therapy can bring,” said Ketan Mehta, founder and CEO at Tris Pharma. “This FDA approval is a significant milestone for the patients, caregivers and physicians who may depend on this medication to treat DMD.

Tris founded Cranbury Pharmaceuticals with the vision to create high-quality, patient-friendly generic medicines that leverage Tris’ strengths in product selection, development and commercial launch. Cranbury will market more than 20 generic medicines and advance a diverse pipeline with the potential to address a range of disorders and diseases. The company will operate out of Tris’ headquarters in Monmouth Junction, New Jersey.

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