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.
