Aurobindo Pharma Limited on Friday, March 1 announced that it has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market Fingolimod Capsules, 0.5 mg. These capsules will be launched in the US market in March 2024.
Fingolimod Capsules, 0.5 mg are prescribed to patients with relapsing forms of multiple sclerosis (MS). The capsules reduce the frequency of clinical exacerbations and delay the accumulation of physical disability in such patients.
The medicine manufactured by Aurobindo Pharma is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation.
The approved product has an estimated market size of $447.3 million for the twelve months ending January 2024, according to IQVIA. Aurobindo claims to have a total of 505 abbreviated new drug application (ANDA) approvals including 486 final approvals and 19 tentative approvals from US FDA.
The Hyderabad-headquartered company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.
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