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news.Eisai has agreed to suspend the development of its experimental proton pump inhibitor (PPI), Pariet/AcipHex (rabeprazole sodium) extended-release (ER) capsules, 50mg.
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The decision was backed by the issuance of a complete response letter (CRL) by the US Food and Drug Administration (FDA) for Pariet/AcipHex ER capsules’ new drug application (NDA).
Following proper discussion with the company, the FDA has asked the company for an additional study for the approval.
Given that the time necessary to complete the additional study will have an impact on its innovativeness in enhancing patient value, the company has decided to terminate the development of the agent.