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The Pharmaceutical Journal Vol 265 No 7123 p743
November 18, 2000 News

US FDA rejects OTC omeprazole proposal

The US Food and Drug Administration has ruled that omeprazole should not become an over-the-counter medicine in the United States. The British Medical Journal for November 4 reported that the decision was based on a belief that patients would not use the medicine correctly without medical supervision. The FDA decided that although tests showed that omeprazole effectively prevented heartburn, consumers associated use of the product with the relief of symptoms, rather than prevention of the condition.