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FDA approves Perrigo ANDA for Lansoprazole capsules

The FDA has approved Perrigo Company's abbreviated new drug application (ANDA) for Lansoprazole capsules of strength 15mg.

The company has begun the shipment of the product, which is bioequivalent to Novartis’ Prevacid OTC 24 hour capsules (15mg) and is indicated for the treatment of frequent heartburn, which occurs two or more days in a week.

Perrigo chairman, president and CEO Joseph Papa said, "This is another example of Perrigo’s continued leadership and commitment to bring key new products to the store brand OTC market. Perrigo continues to be focused on our mission of making quality healthcare more affordable for consumers."

Perrigo Company is a healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients (API).