By: IPP Bureau
Last updated : January 31, 2025 7:55 am
Everolimus TFOS is a kinase inhibitor indicated in adult and paediatric patients aged one year and older with tuberous sclerosis complex for the treatment of subependymal giant cell astrocytoma
NATCO Pharma Limited has announced approval of its ANDA for Everolimus tablets for oral suspension (TFOS), 2mg, 3mg and 5mg, a generic version of AFINITOR DISPERZ by Novartis Pharmaceutical Corporation. NATCO’s marketing partner for the ANDA, Breckenridge Pharmaceutical, Inc plans to launch the product immediately in the US market.
Everolimus TFOS is a kinase inhibitor indicated in 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.
Everolimus tablets for oral suspension (TFOS), 2mg, 3mg and 5mg, had estimated sales of USD 112 million in the U.S. for 12 months ending Sep’24 as per industry sales data.
NATCO Pharma has 9 manufacturing sites and 2 R&D facilities in India. The company’s manufacturing facilities are approved by several leading regulatory authorities like USFDA, Brazil ANVISA, Health Canada, WHO and others catering to 50+ global markets.