Breckenridge Pharmaceutical Inc, the US subsidiary of Spanish pharmaceutical company Towa International, announced on Wednesday that it has received final approval from the US Food and Drug Administration (FDA) for Everolimus Tablets for Oral Suspension (TFOS), 2mg, 3mg and 5mg, a generic version of AFINITOR DISPERZ by Novartis (SWX:NOVN).

The company's partner Natco Pharma Limited, India holds the ANDA and Breckenridge plans to launch the product immediately.

Everolimus TFOS, a kinase inhibitor, is indicated for the treatment of adult and paediatric 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.