Eisai: All-case Surveillance Condition for Approval of “Actonel 17.5 mg tablets” for Treatment of Paget’s Disease of Bone Cleared in Japan
EA Pharma Co., Ltd. and its parent company Eisai Co., Ltd. announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has given notification of the results of reexamination to the effect that the “all-case surveillance” specified drug use-results survey condition required for the approval of “Actonel 17.5 mg tablets” (risedronate sodium hydrate) indicated for the treatment of Paget’s disease of bone has been lifted. In July 2008, MHLW approved the indication for treatment of “Paget’s disease of bone” for…
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