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Aurobindo Receives FDA Approval for Fingolimod Capsules, 0.5 mg

Published: February 28, 2024

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Fingolimod Capsules, 0.5 mg. Aurobindo Pharma’s Fingolimod Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Gilenya Capsules manufactured by Novartis Pharmaceuticals Corporation.

Fingolimod Capsules are 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.