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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, 0.5mg. Aurobindo Pharma’s fingolimod capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Gilenya Capsules manufactured by Novartis Pharmaceuticals Corp.
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.
Fingolimod capsules has an estimated market size of US $483 Million for the twelve months ending Dec 2023, as per IQVIA.
