New Delhi: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fingolimod Capsules, 0.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis). Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolatedsyndrome, relapsing-remitting disease, and active secondary progressive disease in patients 10 years of age and older. Refer label for a detailed indication.
Fingolimod Capsules, 0.5 mg, have an estimated market size of US$ 145 million for twelve months ending December 2025 according to IQVIA.
Alembic has a cumulative total of 237 ANDA approvals (219 final approvals and 18 tentative approvals) from USFDA.
