Global pharma major Lupin Limited on Monday announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Migalastat Capsules, 123 mg.
According to the company’s statement, the approval has been granted to market a generic equivalent of Galafold Capsules, 123 mg of Amicus Therapeutics US LLC. This product will be manufactured at Lupin’s Goa facility in India.
Migalastat Capsules are indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.
Migalastat Capsules (RLD Galafold) had estimated annual sales of USD 388 million in the U.S. (IQVIA MAT December 2023).
