Cranbury Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for the first generic version of Emflaza oral suspension (deflazacort) to treat Duchenne muscular dystrophy (DMD).
The approved abbreviated new drug application (ANDA) of the company is for the use of Emflaza in DMD patients aged five years and older.
Originally, Emflaza was approved in the US in 2017. It was based on results from a clinical study of 196 patients which showed improvements in a clinical assessment of muscle strength across several muscles compared to those taking a placebo.
In February 2024, India-based Aurobindo Pharma secured FDA approval for deflazacort generic to treat DMD in patients five years of age and older. The company gained approval to manufacture and market deflazacort tablets which are bioequivalent and therapeutically equivalent to the reference listed drug Emflaza tablets of PTC Therapeutics.
Cranbury Pharmaceuticals is a newly created fully-owned subsidiary of Tris Pharma. The new entity’s goal is to create patient-friendly generic medications, using its expertise in product curation, development, and market introduction.
Cranbury Pharmaceuticals president Janet Penner said: “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.”
Headquartered in New Jersey, Cranbury Pharmaceuticals will commercialise over 20 generic drugs to the market and advance a pipeline aimed at various disorders and diseases.
Recently, Tris Pharma launched Tris Digital Health, a venture dedicated to the development and launching of digital diagnostic and therapeutic solutions for neurological conditions.
Additionally, Tris Pharma is expanding its commercial lineup of approved, attention-deficit/hyperactivity disorder (ADHD) products, a late-stage pipeline of therapeutics in pain, ADHD, neurological disorders, and addiction.
