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OTC Cholesterol Drugs May Be Revisited By FDA In 2000

This article was originally published in The Tan Sheet

Executive Summary

FDA will re-examine the question of potential Rx-to-OTC switches of hypercholesterolemia drugs in 2000, including reexamination of a 1997 guidance finding such drugs inappropriate for over-the-counter sale, Center for Drug Evaluation & Research Director Janet Woodcock, MD, said Dec. 16.

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FDA may be moving toward softening its firm stance, announced in a 1997 guidance, against over-the-counter use of cholesterol-lowering drugs.

Cholesterol Rx Drugs Reported Topic Of July NDAC Meeting

FDA may be moving toward softening its firm stance, announced in a 1997 guidance, against over-the-counter use of cholesterol-lowering drugs.

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