Cranbury Pharmaceuticals (Cranbury), a wholly-owned subsidiary of Tris Pharma, has announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for the first generic version of Emflaza® oral suspension (deflazacort). This medication is now available in the United States for treating Duchenne muscular dystrophy (DMD).
Deflazacort oral suspension is intended for patients aged five years and older with DMD, a rare genetic disorder marked by progressive muscle degeneration and weakness, primarily affecting boys with early childhood onset. DMD occurs in approximately 1 in 5,000 live male births, with an estimated 20,000 new cases diagnosed globally each year.
“Tris Pharma established Cranbury to continue our commitment to developing high-quality medicines and making them accessible to those in need,” said Janet Penner, president of Cranbury Pharmaceuticals. “The launch of deflazacort oral suspension aligns with this mission, and we are proud to offer this critical therapy to the DMD community.”
Cranbury Pharmaceuticals was founded by Tris Pharma to create high-quality, patient-friendly generic medicines utilizing Tris’ expertise in product selection, development, and commercialization. Cranbury plans to market over 20 generic medicines and advance a diverse pipeline targeting various disorders and diseases. The company operates from Tris’ headquarters in Monmouth Junction, New Jersey.
“Duchenne muscular dystrophy is a devastating disease with limited treatment options. The availability of a generic therapy is crucial for greater accessibility,” said Ketan Mehta, founder and CEO of Tris Pharma. “This FDA approval is a significant milestone for the patients, caregivers, and physicians relying on this medication for DMD treatment. We will continue to expand our generic offerings through Cranbury Pharmaceuticals.”
The launch of Cranbury Pharmaceuticals follows Tris Pharma’s recent introduction of Tris Digital Health, focusing on digital diagnostic and therapeutic products for neurological health conditions. These subsidiaries facilitate significant progress and growth in Tris’ digital health and generics portfolios. Tris Pharma remains dedicated to expanding its commercial portfolio of ADHD products and advancing its pipeline of therapeutics for pain, ADHD, neurological disorders, and addiction.
Indication
DEFLAZACORT oral suspension is a corticosteroid indicated for treating Duchenne muscular dystrophy (DMD) in patients aged 5 years and older.
Important Safety Information
Contraindications: DEFLAZACORT is contraindicated in patients with known hypersensitivity to deflazacort or any inactive ingredients in the oral suspension.
Warnings & Precautions:
- Endocrine Function: Monitor for Cushing’s syndrome, hyperglycemia, and adrenal insufficiency. Gradually taper off corticosteroids to avoid acute adrenal insufficiency.
- Infection Risk: Increased risk of severe infections; advise patients to avoid exposure to chickenpox or measles.
- Cardiovascular/Renal Function: Monitor for blood pressure changes; consider dietary salt restriction and potassium supplementation.
- Gastrointestinal Perforation: Increased risk in patients with gastrointestinal disorders; avoid use if there is a high risk of perforation.
- Psychiatric Reactions: Monitor for mood swings, euphoria, insomnia, and depressive episodes; advise seeking medical attention if symptoms worsen.
- Bone Effects: Prolonged use can increase osteoporosis risk; monitor bone mineral density.
- Ophthalmic Effects: Monitor intraocular pressure with prolonged use.
- Vaccination: Avoid live vaccines; administer live vaccines at least 4 to 6 weeks before starting deflazacort.
- Skin Rashes: Discontinue use if toxic epidermal necrolysis is suspected.
- Growth and Development: Monitor growth in children on long-term therapy.
- Thromboembolic Events: Use with caution in patients at risk of thromboembolism.
Adverse Reactions: Common adverse reactions include Cushingoid appearance, weight gain, increased appetite, upper respiratory tract infection, cough, frequent urination, hirsutism, central obesity, and nasopharyngitis.
Drug Interactions: Avoid moderate or strong CYP3A4 inducers, as they may reduce efficacy.
Report adverse reactions to Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Cranbury Pharmaceuticals, a subsidiary of Tris Pharma, focuses on developing and commercializing high-quality, patient-friendly products. Cranbury plans to market over 20 generic products and transform innovative ideas into effective medicines. Learn more at www.cranburypharma.com.
