Thursday, December 13, 2007

Mevacor's future as an OTC to help lower LDL cholesterol looks dim

Merck & Co., Inc. had hoped that the third time might be the charm, and that the FDA might approve of the use of over-the-counter MEVACOR(R) (lovastatin) 20 mg to help lower LDL cholesterol (something that might prevent a first heart attack)

Merck & Co. announced today that the U.S. Food and Drug Administration's joint panel of the Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted against recommending approval for the use of Mevacor at this time. Making this the third time the agency has rejected Merck's efforts to market Mevacor as an over-the-counter drug.

While the FDA is not bound by the committee's recommendation, they do take the advice of those committees into consideration when making their final decision. The decision is expected to be issued by the FDA on January 26, 2008.

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