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Home » FDA Advisors Vote Down Tolvaptan Due to Lack of Data
FDA Advisors Vote Down Tolvaptan Due to Lack of Data
August 14, 2013
Citing missing data and a serious risk of liver injury, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9 to 6 against recommending approval of Otsuka’s tolvaptan to treat autosomal dominant polycystic kidney disease (ADPKD).