Eisai Aciphex H. Pylori indication
This article was originally published in Pharmaceutical Approvals Monthly
Eisai's Aciphex (rabeprazole) clears FDA Nov. 8 for seven-day treatment of H. pylori infection in combination with amoxicillin and clarithromycin. Approval comes with postmarketing requirements for additional animal toxicity studies after findings of hindquarter paralysis and overt toxicity. Aciphex is the first proton pump inhibitor to be approved for a seven-day treatment regime
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