#United States #FDA Approval #Berkeley Heights #Everolimus #Breckenridge

Breckenridge Pharmaceutical Secures FDA Approval for Everolimus Tablets

On January 29, 2025, Breckenridge Pharmaceutical, Inc. proudly announced that the U.S. Food and Drug Administration (FDA) has approved its Everolimus Tablets for Oral Suspension (TFOS). This approval signifies a major advancement in access to generic pharmaceuticals, providing a vital alternative for patients requiring treatment for tuberous sclerosis complex (TSC). The new medication is available in doses of 2mg, 3mg, and 5mg and is an AB-rated generic equivalent to Novartis Pharmaceuticals' AFINITOR DISPERZ®.

Breckenridge, a subsidiary of Towa International, identifies this launch as a core component of its ongoing strategic plan to bolster its presence within the institutional medication channel. By continuously expanding its product offerings, Breckenridge aims to promote a wider array of treatments in the realms of oncology, autoimmune disorders, and rare diseases. This latest launch reflects its commitment to providing innovative solutions that cater to diverse patient needs, particularly focusing on pediatric oncology, a field where access to effective treatment can significantly alter outcomes.

The new Everolimus TFOS is particularly indicated for pediatric patients aged one year and older diagnosed with subependymal giant cell astrocytoma (SEGA). This condition often requires therapeutic intervention due to its challenging nature in being curatively managed through surgical resection. The introduction of this medication, therefore, represents hope for improved clinical management and quality of life for young patients grappling with this illness.

Brian Guy, the President and Chief Commercial Officer of Breckenridge Pharmaceutical, emphasized the importance of this development. He noted, "The approval and launch of our Everolimus TFOS marks a significant milestone for Breckenridge as we continue to facilitate access to high-quality, affordable medicines for those in need. This launch reinforces our commitment to supporting the U.S. healthcare system and aligns seamlessly with Towa International's vision of enhancing accessibility to medications on a global scale."

In addition to the Everolimus TFOS launch, Breckenridge is introducing its inaugural copay assistance program in the United States. This initiative aims to lighten the financial burden for eligible patients, thereby improving their access to essential treatments. Copay cards are instrumental in fostering patient adherence to prescribed regimens by mitigating out-of-pocket expenses. This move signifies a critical part of Breckenridge's broader objective to enhance its social impact and showcase its dedication to public health.

Breckenridge’s focus extends beyond traditional pharmaceuticals as it seeks to adapt to emerging healthcare needs while maintaining generics as the anchor of its portfolio. With this approach, the company is set to facilitate comprehensive healthcare solutions, further exemplified by the copay assistance program, which reflects on the ethos of patient-centered care.

For more information about the Everolimus TFOS copay assistance program or to ascertain patient eligibility, you can visit the upcoming section on Breckenridge's official website at www.breckenridgepharma.com. This site will provide full prescribing information including important warnings, precautions, adverse reactions, and contraindications related to Everolimus TFOS.

Breckenridge Pharmaceutical, Inc. stands as a beacon of affordable healthcare, aligning with its partners worldwide to deliver quality generics to U.S. patients. By focusing on reliable supply, superior customer service, and commitment to patient care, Breckenridge continuously strives to enhance the health of communities it serves.

About Breckenridge Pharmaceutical, Inc.

Breckenridge, located in New Jersey and under the umbrella of Towa International based in Barcelona, Spain, is committed to providing cost-efficient generic pharmaceuticals. Through collaboration with manufacturers across the globe, the company is dedicated to improving patient health experiences by delivering high-quality medications through reliable and timely supply chains.

For further inquiries or more information about their services, please reach out to Towa International / Breckenridge Pharmaceutical, Inc. External Communications and Investor Relations team at [email protected].