Otsuka Receives Approval of Samsca in Japan

  • Otsuka Pharmaceutical Co., Ltd. (Otsuka) has received regulatory approval for a pharmacological treatment of autosomal dominant polycystic kidney disease (ADPKD) through the approval of Samsca® (tolvaptan) in Japan in 7.5-mg and 15-mg tablet forms for extended use for the additional indication of ADPKD. Also, the new dosage form of 30-mg Samsca tablets has received approval for the indication of ADPKD.

  • The drug was submitted for regulatory approval in Europe in December 2013. In the US, FDA’s Cardiovascular and Renal Drugs Advisory Committee voted not to approve tolvaptan for the treatment of ADPKD in August 2013. Otsuka says based on a review issued by the FDA, the company has continued discussions with the agency regarding supplementary data and the path forward for resubmission.

    Source:Otsuka Pharmaceutical 



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