USFDA25 Apr 2026, 12:00 pm
Alembic Pharma Gets USFDA Nod for Fingolimod Capsules
AI Summary
Alembic Pharmaceuticals Ltd. has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fingolimod Capsules, 0.5 mg. This ANDA is therapeutically equivalent to Novartis' Gilenya Capsules, 0.5 mg. Fingolimod is used to treat relapsing forms of multiple sclerosis. The market size for Fingolimod Capsules, 0.5 mg, is estimated at US$ 145 million for the twelve months ending December 2025, according to IQVIA. Alembic now has a total of 237 ANDA approvals from the USFDA.
Key Highlights
- Alembic receives USFDA final approval for Fingolimod Capsules, 0.5 mg.
- The approved ANDA is equivalent to Novartis' Gilenya Capsules, 0.5 mg.
- Fingolimod treats relapsing forms of multiple sclerosis.
- Fingolimod Capsules have an estimated market size of US$ 145 million.
- Alembic now has 237 ANDA approvals from USFDA.