Hyderabad, Aug 30: Granules India Limited on Tuesday announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC).
It is bioequivalent to the reference listed drug product, Imodium Multi-Symptom Relief Tablets, 2 mg/125 mg, of Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Granules Company said in a release here.
Loperamide Hydrochloride and Simethicone Tablets are indicated to relieve symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.
Granules now have a total of 52 ANDA approvals from US FDA (50 Final approvals and 2 tentative approvals).
The Imodium Multi-Symptom Relief brand and store brands had combined U.S. sales of approximately $60 million MAT for the most recent 12 months, the release added. (UNI)
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