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U.S. FDA Gives Japan’s Eisai Priority Review For Aciphex Reflux Drug

This article was originally published in PharmAsia News

Executive Summary

Eisai's Aciphex (rabeprazole) has been given priority-review status by the U.S. FDA, which is to rule within six months on a supplemental NDA for the proton pump inhibitor for treating acid reflux. The fast-track review of the Japanese company's drug is for its use as a short-term treatment of gastroesophageal reflux in patients between the ages of 12 and 16. The class of drugs to which Aciphex belongs works on reflux by suppressing the production of stomach acid. (Click here for more
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