BERKELEY HEIGHTS, N.J., Jan. 29, 2025 – Breckenridge Pharmaceutical, Inc., -the U.S. subsidiary of Towa International that markets, distributes, and sells generic pharmaceuticals in the United States, – announced today that the Food and Drug Administration (FDA) has granted final approval of Everolimus Tablets for Oral Suspension (TFOS), 2mg, 3mg and 5mg, a generic version of AFINITOR DISPERZ® by Novartis Pharmaceuticals Corporation. The ANDA is held by its partner Natco Pharma Limited, India and Breckenridge plans to launch immediately.
Everolimus TFOS is a kinase inhibitor indicated in adult and pediatric patients aged one year and older with tuberous sclerosis complex (“TSC”) for the treatment of subependymal giant cell astrocytoma (“SEGA”) that requires therapeutic intervention but cannot be curatively resected.
This new launch is part of Breckenridge’s strategic plan, embodying the company’s short and medium-term strategy of expanding its presence in the institutional channel and enhancing its portfolio. By introducing a diverse range of oncology, autoimmune, rare disease, and supportive care products to the U.S. market, Breckenridge reaffirms its commitment to enhancing patient access to medicines and providing more therapeutic solutions to meet their needs. This launch also reflects the company’s global mission of contributing to people’s health and marks a significant milestone as Breckenridge enters the field of pediatric oncology.
Brian Guy, President and CCO of Breckenridge Pharmaceutical, states, “The approval and launch of our Everolimus TFOS represents a significant milestone for Breckenridge as we continue to expand access to high-quality, affordable medicines for patients in need. This launch not only reinforces our commitment to supporting the U.S. healthcare system but also aligns with Towa International’s mission of reaching as many people as possible worldwide. Additionally, this milestone is further highlighted by the introduction of our first-ever copay assistance program for Everolimus TFOS, continuing our commitment to improving patient access to medications.”
A step forward in access: new copay assistance program for Everolimus TFOS
In conjunction with Breckenridge’s launch of Everolimus TFOS, the company will launch its first prescription copay assistance program in the United States. Access to crucial treatments is paramount, and this program will improve access by assisting in reducing the out-of-pocket cost of treatment for eligible patients. Co-pay cards play a vital role in helping patients manage their healthcare costs and maintain their treatment regimens. This initiative represents a significant step forward in Breckenridge’s strategic plan and marks the company’s commitment to expanding its social impact. Breckenridge is dedicated to becoming a leading force in health, focusing on emerging areas within the health sector while maintaining generic pharmaceuticals as the core of its business.
For more information and to determine patient eligibility for enrollment in Breckenridge’s Everolimus TFOS copay assistance program, please visit the Copay Assistance Program section on www.breckenridgepharma.com, which will be available soon.
*Please visit www.breckenridgepharma.com for the full prescribing information for warnings and precautions, adverse reactions and contraindications.
**All brand names and trademarks are the property of their respective owners.
About Breckenridge Pharmaceutical, Inc.:
Breckenridge Pharmaceutical, Inc., (New Jersey), the U.S. subsidiary of Towa International (Barcelona, Spain), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients. With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we strive to impact the health of the patients we and our customers serve.
For further information, please contact:
Towa International / Breckenridge Pharmaceutical, Inc.
External Comm and IR team
Email: media@towapharmaceutical.com
