Natco Pharma's Generic Breakthrough: Everolimus Approval

Natco Pharma has gained approval from the US health regulator for its generic version of Everolimus tablets for patients with tuberous sclerosis complex. The drug, aimed at treating Subependymal Giant Cell Astrocytoma, will be launched in the US market by Breckenridge Pharmaceutical, its marketing partner.

Natco Pharma Ltd has achieved a significant milestone with the approval from the US health regulator for its generic version of Everolimus tablets for oral suspension. This approval marks a key step forward for patients with tuberous sclerosis complex.

The green light from the regulator covers the Abbreviated New Drug Application (ANDA) for Everolimus tablets in strengths of 2mg, 3mg, and 5mg. Natco's marketing partner, Breckenridge Pharmaceutical, has announced plans to launch the product immediately in the US market.

This development is crucial for adults and children aged one year and older suffering from Subependymal Giant Cell Astrocytoma (SEGA), a rare benign tumor that requires treatment. The generic drug had estimated US sales of USD 112 million over the past year, indicating significant market potential.

(With inputs from agencies.)