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ALLEGAN, Mich. — Perrigo Co. has received tentative approval from the Food and Drug Administration for its Abbreviated New Drug Application (ANDA) to market over-the-counter omeprazole and sodium bicarbonate capsules (20mg/1100mg).
The company said Tuesday that the product, which it expects to launch on the date when market formation occurs, is the store-brand equivalent to Merck’s Zegerid OTC.
A proton pump inhibitor indicated to ease frequent heartburn, Zegerid OTC had sales of about $42 million through food, drug and mass merchandisers over the last 12 months, Perrigo reported.
"Our research and development group worked diligently to achieve this milestone," Perrigo chairman and chief executive officer Joseph Papa stated. "This is another excellent example of Perrigo’s investment and commitment to making quality health care more affordable for our customers."
