NATCO announces approval of its Abbreviated New Drug Application (ANDA) for Everolimus tablets for Oral Suspension (generic of AFINITOR DISPERZ®)

Hyderabad, India, January 30th, 2025: NATCO Pharma Limited (BSE: 524816 and NSE: NATCOPHARM) ("NATCO") today announces 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. *Safe Harbor Statement: All brand names and trademarks are the property of their respective owners

The release as fetched from its publisher. natcopharma.co.in ↗