Perrigo: FDA Tentative Approval For OTC Omeprazole-Sodium Bicarbonate
ALLEGAN — Allegan-based Perrigo Co. (Nasdaq: PRGO) today announced that it has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application to market over-the-counter omeprazole and sodium bicarbonate capsules 20mg/1100mg, the store brand equivalent to Merck & Co.’s Zegerid OTC.
Zegerid OTC (omeprazole and sodium bicarbonate capsules 20mg/1100mg), a proton pump inhibitor indicated to relieve frequent heartburn, had sales of approximately $42 million through food, drug and mass merchandisers for the last 12 months.
“Our research and development group worked diligently to achieve this milestone,” said Perrigo chairman, president and CEO Joseph C. Papa. “This is another excellent example of Perrigo’s investment and commitment to making quality healthcare more affordable for our customers.”
Perrigo develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, dietary supplements and active pharmaceutical ingredients. The company is the world’s largest manufacturer of OTC pharmaceutical products for the store brand market. The Company’s primary markets and locations of logistics operations have evolved over the years to include the United States, Israel, Mexico, the United Kingdom, India, China and Australia.
More at www.perrigo.com.