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Perrigo wins FDA approval fo romeprazole and sodium bicarbonate capsules, 20mg/1100mg

The U.S. Food and Drug Administration has approved Perrigo'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.

Perrigo's CEO John T. Hendrickson stated, "This OTC product approval and launch illustrates Perrigo's commitment to providing customers and consumers with high quality value alternatives in important treatment categories.

"Important product launches like the store brand version of Zegerid OTC are what drive Perrigo's ability to provide Quality Affordable Healthcare Products to customers and consumers around the world."