FDA approves generic Emflaza for children with Duchenne muscular dystrophy

The FDA has approved an abbreviated new drug application for a generic version of Emflaza to treat Duchenne muscular dystrophy, according to the manufacturer.

Tris Pharma and its newly formed subsidiary Cranbury Pharmaceuticals said in a press release that the generic form of Emflaza (deflazacort), an oral suspension corticosteroid, is now available for patients aged 5 years and older in the United States.

Duchenne muscular dystrophy is a rare genetic disorder characterized by progressive muscle degeneration and weakness that primarily affects boys, with symptom onset in early childhood. The condition occurs in approximately 1 in 5,000 live male births and an estimated 20,000 children worldwide are diagnosed each year, according to the release.

“This FDA approval is a significant milestone for the patients, caregivers and physicians who may depend on this medication to treat [Duchenne muscular dystrophy],” Ketan Mehta, founder and CEO at Tris Pharma, said in the release.