The FDA Greenlights Generic Deflazacort for the Treatment of Duchenne Muscular Dystrophy

Cranbury Pharmaceuticals, a subsidiary of Tris Pharma (Monmouth Junction, NJ) announced that the Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for a generic version of Emflaza (deflazacort; PTC Therapeutics, Warren, NJ) as an oral suspension to treat Duchenne Muscular Dystrophy (DMD). The ANDA approval means that the generic deflazacort oral suspension is now available in the United States to treat people with DMD aged 5 years and older.

According to a statement from Tris Pharma, the company founded its subsidiary, Cranbury Pharmaceuticals, to develop and market generic medications to increase the accessibility of therapies for diverse disorders and diseases. Cranbury Pharmaceuticals is the second company to receive an approval for a generic version of deflazacort, following the approval of Aurobindo Pharma’s (Hyberabad, India) generic deflazacort tablets early in 2024.

“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. Our portfolio of differentiated, high-quality generic medications has always been core to our business at Tris, and I look forward to continuing to expand our generic offerings under our new subsidiary, Cranbury Pharmaceuticals.”

Deflazacort is a corticosteroid first approved by the FDA in 2017 as Emflaza, and in 2019, the medication’s indication was expanded to include children aged 2 to 5 years.