FDA approves Granules India Limited’s generic diarrhea relief tablets

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.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.According to the FDA, the most common adverseRead More