Natco Pharma gets ANDA approval for Everolimus tablets for oral suspension

30 Jan 2025 Evaluate

Natco Pharma has received Abbreviated New Drug Application (ANDA) approval 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 $112 million in the U.S. for 12 months ending September 24 as per industry sales data. 

Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets. 


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