Cranbury Pharmaceuticals Receives FDA Approval for First Generic Version of Emflaza Oral Suspension

Cranbury Pharmaceuticals, a wholly-owned subsidiary of Tris Pharma, today announced the U.S. Food and Drug Administration (FDA) approved the Abbreviated New Drug Application (ANDA) for the first generic version of Emflaza® oral suspension (deflazacort) for the treatment of Duchenne muscular dystrophy (DMD). The generic deflazacort oral suspension is now available to patients in the United States.

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. DMD occurs in approximately 1 in 5,000 live male births, and it is estimated that about 20,000 children are diagnosed with DMD globally each year.

“Tris Pharma founded Cranbury as part of the company’s continued commitment to develop high-quality medicines and make them accessible to individuals who need them,” said Janet Penner, president at Cranbury Pharmaceuticals. “The launch of deflazacort oral suspension aligns with this commitment, and we are proud to provide this critical therapy to those with DMD. As a tenured member of the Tris team, I am honored to take on the role of president of our new subsidiary and have the opportunity to provide important generic medicines to patients with a range of disorders and diseases.”

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.

“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.”

The spinout of Cranbury Pharmaceuticals follows Tris Pharma’s recent launch of Tris Digital Health, a business focused on the development and commercialization of digital diagnostic and therapeutic products for neurological health conditions. The creation of these subsidiaries within Tris facilitates important progress and enables significant continued growth for the company’s digital health and generics portfolios. Tris Pharma will continue to focus on building its commercial portfolio of approved, best-in-class ADHD products and advancing its late-stage pipeline of innovative therapeutics in pain, ADHD, neurological disorders and addiction.

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