Tuesday, August 6, 2013

U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee Recommends Against Approval of Otsuka Pharmaceutical's Tolvaptan for Use in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Otsuka Pharmaceutical Co., Ltd. announced today the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee voted against approval of tolvaptan for the treatment of ADPKD. The Advisory Committee voted 9 to 6 not to approve tolvaptan for ADPKD. The FDA is not bound by the Committee’s guidance but takes its advice into consideration.

The FDA accepted Otsuka’s new drug application (NDA) for tolvaptan earlier this year, granting the drug a priority review status and assigning a Prescription Drug User Fee Act (PDUFA) goal date of September 1, 2013.

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