U.S. FDA nod for Natco Pharma’s generic of Novartis drug 

Natco Pharma has received U.S. Food and Drug Administration (U.S. FDA) approval for Everolimus tablets for oral suspension, 2mg, 3mg and 5mg, a generic version of Novartis Pharmaceutical Corporation’s Afinitor Disperz.

Marketing partner for its abbreviated new drug application (ANDA), Breckenridge Pharmaceutical Inc., plans to launch the product immediately in the U.S. market, Natco Pharma said on Thursday (January 30, 2025). The Hyderabad-based company’s shares closed less than 1% lower at ₹1,165.15 on the BSE.

Everolimus TFOS, 2mg, 3mg and 5mg, had estimated sales of $112 million in the U.S. for the 12 months ending Sep 2024, it said citing industry sales data. The product 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, Natco Pharma said.