The approved product is the bioequivalent to the reference listed drug product Methergine 0.2 mg
Granules India said its subsidiary has received approval from the US health regulator for Methylergonovine tablets, used for the prevention and control of postpartum haemorrhage.
In a filing to BSE, Granules India said “the US Food and Drug Administration (US FDA) has approved its abbreviated new drug applications (ANDA) for Methylergonovine 0.2 mg tablets.
The ANDA was filed by Granules Pharmaceuticals Inc., a wholly-owned subsidiary of Granules India. The approved product is the bioequivalent to the reference listed drug product Methergine 0.2 mg, it added.