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FDA Advisory Committee Votes Against Tolvaptan

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August 2013

On 5 August, 2013, the US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee met to review the Tolvaptan submission for product licensing.

After hearing presentations from researchers, clinicians, and the public, and reviewing and discussing data, the Advisory Committee voted against approval of tolvaptan.

The FDA is not bound by the Committee’s guidance but will take that advice into consideration when it makes its decision on 1 September, 2013.

It is important to understand that the Committee's decision is not a final one. The FDA’s responsibility is to ensure the safety of drugs and they are conducting the appropriate review of the submission by Otsuka Pharmaceutical Co., Ltd.  

See the link below for a summary of the FDA Advisory Committee's decision:

http://www.medpagetoday.com/Nephrology/GeneralNephrology/40844

Here is Otsuka's press release:
http://www.marketwatch.com/story/us-food-and-drug-administrations-cardiovascular-and-renal-drugs-advisory-committee-recommends-not-to-approve-otsuka-pharmaceuticals-tolvaptan-for-use-in-autosomal-dominant-polycystic-kidney-disease-2013-08-05

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