Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fingolimod Capsules, 0.5 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation. The product will be launched in March 2024.

The approved product has an estimated market size of US$ 447.3 million for the twelve months ending January 2024, according to IQVIA. Aurobindo now has a total of 505 ANDA approvals (486 Final approvals and 19 tentative approvals) from USFDA.

Fingolimod Capsules, 0.5 mg, is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.