Aurobindo Pharma bags USFDA nod for Fingolimod Capsules for multiple sclerosis
Fingolimod Capsules, 0.5 mg, is indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
Hyderabad: Aurobindo Pharma Limited has announced that the Company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fingolimod Capsules, 0.5 mg.
The product is a bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation.
Fingolimod Capsules, 0.5 mg, is 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.
The product will be launched in March 2024.
The approved product has an estimated market size of US$ 447.3 million for the twelve months ending January 2024, according to IQVIA.
Aurobindo now has a total of 505 ANDA approvals (486 Final approvals and 19 tentative approvals) from USFDA.
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Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.
The company has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.
