Granules India has received U.S. Food and Drug Administration (U.S. FDA) approval for its abbreviated new drug application related to Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg (OTC).
The approved product is bioequivalent to the reference listed drug, Imodium Multi-Symptom Relief Tablets, 2 mg/125 mg, of Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. The Imodium Multi-Symptom Relief and store brands had combined U.S. sales of approximately $60 million MAT for the most recent 12 months, Granules said on Tuesday.
Loperamide Hydrochloride and Simethicone tablets are indicated to relieve symptoms of diarrhoea plus bloating, pressure and cramps, commonly referred to as gas, the drugmaker said. Granules now have 52 ANDA approvals from U.S. FDA (50 final and 2 tentative approvals).
