The Food and Drug Administration has approved Perrigo’s loperamide HCl and simethicone tablets, a store-brand equivalent of Imodium Multi-Symptom Relief. The approval, announced Friday, opens up Perrigo to launch the product in the fourth quarter of the year, which the company said it was planning.
The product will be packaged and marketed as store brands or a retailer’s own-brand, Perrigo said. It is indicated to relieve symptoms of diarrhea plus bloating, pressure and cramps. Retail sales totaled roughly $62 million for the past 12 months, according to IRI.
“This final approval and upcoming launch is an important accomplishment for our store brand OTC business,” Perrigo executive vice president and president of consumer healthcare Americas Jeff Needham said. “Key new product launches, such as loperamide hydrochloride and simethicone tablets, 2 mg/125 mg, provide our customers and consumers with high-quality, value alternatives in important treatment categories.”