Perrigo Announces FDA Final Approval and Launch of Store Brand OTC Lansoprazole 15mg Capsules

Perrigo Company

today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for Lansoprazole capsules (15 mg). Shipments of product to customers have already begun. This new product for the U.S. store brand market is bioequivalent to Novartis' Prevacid® 24HR capsules (15 mg) and is indicated for the treatment of frequent heartburn, which occurs two or more days in a week. Sales for Prevacid OTC were approximately $220 million.