Mumbai, Feb. 26 -- The approval covers Everolimus tablets in strengths of 0.25 mg, 0.5 mg, 0.75 mg and 1 mg. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Zortress Tablets, marketed by Novartis Pharmaceuticals Corp.

Everolimus tablets are indicated for the prophylaxis of organ rejection in adult patients undergoing kidney and liver transplants. For kidney transplant patients at low-to-moderate immunologic risk, the drug is used in combination with basiliximab, reduced-dose cyclosporine and corticosteroids. For liver transplant patients, it is administered no earlier than 30 days post-transplant, in combination with reduced-dose tacrolimus and corticosteroids.

The approval was granted to ...