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Merck, BMS Prepare To Seek FDA Reversal On OTC Cholesterol Drugs

This article was originally published in The Tan Sheet

Executive Summary

Merck and Bristol-Myers Squibb are aiming to switch the lowest dosage levels of their respective Rx cholesterol-lowering drugs, Mevacor (lovastatin) and Pravachol (pravastatin), to OTC status. The firms have filed NDAs for approval of OTC 10 mg daily doses.

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OTC Statin Target Population Receives Significant FDA Attention

The type of people most suited for OTC statin therapy received considerable attention from FDA during the agency's discussion on the OTC availability of vascular drugs at a public meeting in Gaithersburg, Md. June 28-29.

OTC Statin Target Population Receives Significant FDA Attention

The type of people most suited for OTC statin therapy received considerable attention from FDA during the agency's discussion on the OTC availability of vascular drugs at a public meeting in Gaithersburg, Md. June 28-29.

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