Perrigo Says FDA Approves ANDA For Omeprazole And Sodium Bicarbonate Capsules

(RTTNews) - Perrigo Company plc (PRGO) said that the U.S. Food and Drug Administration has approved the company's ANDA for omeprazole and sodium bicarbonate capsules, 20mg/1100mg. This approval will initiate the first store brand launch of an equivalent product to Zegerid OTC capsules.

This product will be packaged and marketed as a store brand or retailer 'own label' brands and provides consumers with a high-quality, value alternative to Zegerid OTC®. Shipments to retail customers have already commenced.

Zegerid OTC (omeprazole and sodium bicarbonate capsules, 20mg/1100mg) is indicated for the treatment of frequent heartburn. National brand sales for the twelve months ending June 2016 were $27 million.