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Otsuka's tolvaptan approved for sale in Europe

This article was originally published in Scrip

Executive Summary

The European Commission has granted marketing authorization to Otsuka Pharmaceutical for Jinarc (tolvaptan) for the treatment of autosomal dominant polycystic kidney disease (ADPKD) in adults who have chronic kidney disease (CKD). The US FDA rejected an NDA for the product in this indication in 2013, citing the need for additional data.

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