Natco Pharma Gets US FDA Approval for Generic Everolimus Tablets

New Delhi, Jan 30 (PTI) Natco Pharma Ltd on Thursday said it has received approval from the US health regulator for its generic version of Everolimus tablets for oral suspension indicated for patients with tuberous sclerosis complex.

The approval is for the Abbreviated New Drug Application (ANDA) for Everolimus tablets for oral suspension (TFOS) of strengths 2mg, 3mg and 5mg, Natco Pharma said in a regulatory filing.

The drug is a generic version of AFINITOR DISPERZ by Novartis Pharmaceutical Corporation, it added.

"NATCO's marketing partner for the ANDA, Breckenridge Pharmaceutical, Inc plans to launch the product immediately in the US market," the company said.

Everolimus TFOS is 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), a rare form of benign tumour, that requires therapeutic intervention but cannot be curatively resected, it said.

Everolimus tablets for oral suspension (TFOS), 2mg, 3mg and 5mg, had estimated sales of USD 112 million in the US for 12 months ending Sep'24 as per industry sales data, Natco said.