Monday, July 15, 2024

Duchenne Muscular Dystrophy: FDA Approves Cranbury Pharmaceuticals’ First Generic Emflaza® (deflazacort) Oral Suspension

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Duchenne Muscular Dystrophy is the focus of Cranbury Pharmaceuticals (Cranbury), a wholly-owned subsidiary of Tris Pharma, as they announce the U.S. Food and Drug Administration (FDA) approval of the Abbreviated New Drug Application (ANDA) for the first generic version of Emflaza® oral suspension (deflazacort). This approval marks a significant milestone as the generic deflazacort oral suspension is now available to patients in the United States.

Deflazacort oral suspension is specifically indicated for treating DMD in patients aged five years and older. DMD is a rare genetic disorder that leads to progressive muscle degeneration and weakness, primarily affecting boys with symptom onset in early childhood. The disease occurs in approximately 1 in 5,000 live male births, with an estimated 20,000 children diagnosed globally each year.

Janet Penner on Cranbury Pharmaceuticals’ Launch of Deflazacort for Duchenne Muscular Dystrophy

Janet Penner, President of Cranbury Pharmaceuticals, stated, “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. 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 Pharma established Cranbury Pharmaceuticals with the vision of creating high-quality, patient-friendly generic medicines that leverage Tris’ expertise in product selection, development, and commercial launch. Cranbury is set to market over 20 generic medicines and advance a diverse pipeline with the potential to address a variety of disorders and diseases. The company will operate out of Tris’ headquarters in Monmouth Junction, New Jersey.

Duchenne Muscular Dystrophy

Ketan Mehta Highlights Critical Need for Accessible Duchenne Muscular Dystrophy Treatments with Cranbury Pharmaceuticals’ FDA Approval

Ketan Mehta, Founder and CEO of Tris Pharma, highlighted the critical need for accessible treatment options for DMD. “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. 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 launch of Cranbury Pharmaceuticals follows Tris Pharma’s recent establishment of Tris Digital Health, a business focused on developing and commercializing digital diagnostic and therapeutic products for neurological health conditions. These new subsidiaries within Tris facilitate important progress and enable significant 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.

In summary, the FDA approval of the first generic version of Emflaza® oral suspension by Cranbury Pharmaceuticals represents a pivotal advancement in the treatment of Duchenne muscular dystrophy, offering a more accessible and cost-effective option for patients. Cranbury’s commitment to high-quality generic medicines and Tris Pharma’s broader strategic vision underscore their dedication to addressing unmet medical needs and enhancing patient care across multiple disease states.

Resource: Business Wire, June 12, 2024

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