Breckenridge Pharmaceutical, Inc., announced 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."
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