Alembic Pharmaceuticals received final USFDA approval for Fingolimod Capsules 0.5 mg, a generic version of Novartis' Gilenya.
The approved product addresses a market estimated at $145 million for the twelve months ending December 2025.
This approval brings Alembic's cumulative ANDA approvals to 237 (219 final and 18 tentative approvals).
Fingolimod is indicated for treating relapsing forms of multiple sclerosis in patients aged 10 years and older.