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 
.