Alembic Pharmaceuticals Secures USFDA Approval for Fingolimod Capsules
Alembic Pharmaceuticals receives USFDA approval for Fingolimod Capsules
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Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Fingolimod Capsules, 0.5 mg, a treatment for multiple sclerosis. This approval positions Alembic to compete in a market projected to reach $145 million by December 2025.
- 01Alembic Pharmaceuticals received USFDA approval for Fingolimod Capsules, 0.5 mg.
- 02Fingolimod is a treatment for various forms of multiple sclerosis.
- 03The approved drug is equivalent to Novartis' Gilenya Capsules.
- 04The market for Fingolimod Capsules is estimated at $145 million by December 2025.
- 05This approval enhances Alembic's portfolio in the neurology sector.
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Alembic Pharmaceuticals has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Fingolimod Capsules, 0.5 mg. This drug is a sphingosine 1-phosphate receptor modulator, indicated for treating relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome and active secondary progressive disease in patients aged 10 years and older. The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to Novartis Pharmaceuticals Corporation's Gilenya Capsules, 0.5 mg. The market for Fingolimod Capsules is projected to reach approximately $145 million for the twelve months ending December 2025, according to data from IQVIA. This approval not only broadens Alembic's product offerings but also positions the company competitively in the growing neurology market.
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