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FDA advisory panel votes no on fixed-dose statin plus aspirin, cites titration concerns. (Pravastatin-Aspirin Combination).

Publication: Internal Medicine News

Publication Date: 15-FEB-02

Author: Mechcatie, Elizabeth
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COPYRIGHT 2002 International Medical News Group

SILVER SPRING, MD. -- The potential for inadequate titration was among the concerns that led the majority of a Food and Drug Administration expert panel to recommend against a fixed-dose combination of the lipid-lowering drug pravastatin and buffered aspirin.

At a meeting of the FDA's Cardiovascular and Renal Drugs Advisory Committee, the panel voted 7-1, with one abstention, against recommending approval of the combination, which would be available as 40 mg of pravastatin with either 81 mg or 325 mg of buffered aspirin. The FDA usually follows the recommendations of...

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