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news.The US Food and Drug Administration (FDA) has awarded a tentative approval to Perrigo's abbreviated new drug application (ANDA) for over-the-counter (OTC) version of omeprazole and sodium bicarbonate capsules, designed for relieving heartburn.
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The OTC version of omeprazole and sodium bicarbonate capsules, which are available in 20mg/1100mg dosages, are store brand generic equivalent to Merck & Co’s Zegerid OTC.
Zegerid OTC is a proton pump inhibitor indicated to relieve frequent heartburn symptoms.
Perrigo chairman, president and CEO Joseph Papa said the company’s research and development group worked diligently to achieve the milestone.
"This is another excellent example of Perrigo’s investment and commitment to making quality healthcare more affordable for our customers," Papa added.
The company said for the last 12 months, the brand-name version had sales of approximately $42m.