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Bristol pravastatin/aspirin co-package

Executive Summary

Bristol-Myers Squibb's NDA (21-387) for a pravastatin/aspirin co-package (tentatively named Pravaguard) will return to FDA's Cardiovascular & Renal Drugs Advisory Committee for consideration on the afternoon of July 18. The NDA was resubmitted following a Jan. 18 meeting at which the committee voted against approval for long-term management to reduce the risk of cardiovascular events in patients with clinically evident coronary heart disease (1"The Pink Sheet" Jan. 21, p. 7)...

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