Issue: October 2022
Fact checked byRobert Stott

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September 03, 2022
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FDA approves Granules India Limited’s generic diarrhea relief tablets

Issue: October 2022
Fact checked byRobert Stott
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Granules India Limited received FDA approval of its abbreviated new drug application for loperamide hydrochloride and simethicone tablets indicated for diarrhea symptom relief, according to a press release.

Perspective from Adrienna Jirik, MD

The FDA determined that, among adult patients with symptoms of diarrhea, bloating, pressure and cramps, Granules India’s loperamide hydrochloride and simethicone (2 mg/125 mg) product is therapeutically equivalent to Johnson & Johnson’s Imodium Multi-Symptoms Relief Tablets (2 mg/125 mg), which was used as a reference product.

Man with Stomach Pain
Source: Adobe Stock

According to the FDA, the most common adverse events associated with the combination of loperamide hydrochloride and simethicone is dizziness, dry mouth and nausea.