Natco Pharma receives approval for its ANDA for Everolimus tablets for oral suspension

Natco Pharma 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.

 

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