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Eisai

Eisai: All-case Surveillance Condition for Approval of “Actonel 17.5 mg tablets” for Treatment of Paget’s Disease of Bone Cleared in Japan

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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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Eisai: Dayvigo (Lemborexant) Approved for Treatment of Insomnia in Japan

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Eisai: Dayvigo (Lemborexant) Approved for Treatment of Insomnia in Japan

Eisai Co., Ltd. announced today that it has obtained the manufacturing and marketing approval in Japan for its in-house discovered orexin receptor antagonist DAYVIGO (2.5mg, 5mg, and 10mg tablets, lemborexant) for treatment of insomnia. DAYVIGO is a dual orexin receptor antagonist that inhibits orexin neurotransmission regulating sleep-wake rhythm by binding competitively to the two subtypes of orexin receptors (OX1R and OX2R). Blocking the binding of wake-promoting neuropeptides orexin to orexin receptors is thought to suppress wake drive by balancing sleep-wake…

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