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Takeda Heartburn Drug Encounters Delay At U.S. FDA

This article was originally published in PharmAsia News

Executive Summary

A heartburn drug of Takeda's U.S. arm has encountered a snag in its effort to gain approval by the U.S. FDA. The agency notified Takeda Pharmaceuticals of North America it would not be able to complete a review as expected by the end of October. At issue is the TAK-390MR proton pump inhibitor intended for treating gastroesophageal reflux disease and other serious acid-related problems. The agency told Takeda it would need another three months to review all the data supplied by Takeda. A spokesman said Takeda's drug has elements that differ from existing proton pump inhibitors. (Click here for more
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