Samsca approved in Japan for Polycystic Kidney Diease - Otsuka

Samsca (tolvaptan), from Otsuka, has been approved in Japan as the first drug treatment in the world to slow the progression of autosomal dominant Polycystic Kidney Disease (ADPKD). It has been approved 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.

In Europe, as of December, 2013, an application for regulatory approval of tolvaptan in ADPKD had been received and is under review. In the United States, based on a review issued by the FDA, Otsuka has continued discussions regarding supplementary data and the path forward for resubmission.