FDA gives tentative OK for Lupin’s generic Galafold
Migalastat Capsules are indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene variant based on in vitro assay data.
Lupin has received tentative approval from the Food and Drug Administration for Migalastat Capsules, 123 mg, which is a generic of Amicus Therapeutics’ Galafold.
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 variant based on in vitro assay data.
[Read more: Lupin receives FDA OK for generic Banzel]
Migalastat Capsules had a market value of $388 million for the year ending December 2023, Lupin said.
[Read more: Lupin receives FDA nod for 3 generics]