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No.1111February 2, 2011 EISA Co., Ltd.EISA RECEIVES COMPLETE RESPONSE LETTER FROM U.S. FDA FOR INVESTIGATIONAL PROTON PUMP INHIBITOR EXTENDEDRELEASE CAPSULES, 50 MG EISA Co., Ltd. (Headquarters: Tokyo,
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Eisai receives complete response is a notification from regulatory authorities indicating that the review process for a particular drug application has been completed.
The pharmaceutical company Eisai is required to file the complete response when they receive it from regulatory authorities.
Eisai must carefully review the complete response and provide any additional information or clarification requested by the authorities.
The purpose of the complete response is to address any remaining concerns or questions that regulatory authorities may have about the drug application.
Eisai must report any requested additional information, clarification, or updates related to the drug application.
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