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FDA reject OTC statin

WASHINGTON (Reuters) - U.S. regulators have rejected Merck & Co Inc's
bid to sell its Mevacor cholesterol-lowering drug without a
prescription, the company said on Friday.

Merck said the Food and Drug Administration indicated in a letter that
it would require a revised label and additional data from the company
to gain approval for nonprescription sales of Mevacor.

The drug is a part of the widely used class of prescription
cholesterol-lowering medicines known as statins.

In December, a U.S. advisory panel urged the government to reject
Merck's third bid to sell the cholesterol-lowering drug without a
prescription.

Currently all cholesterol-lowering drugs require a doctor's
prescription before being dispensed in the United States.

Mevacor is one of the statin drugs taken by millions to cut
cholesterol and the risk of heart disease, the leading killer of
Americans. Other prescription statins include Merck's Zocor and Pfizer
Inc's Lipitor.

Panel members worried that such higher-risk patients might take over-
the-counter Mevacor rather than a more-potent prescription statin.

(Reporting by Lisa Richwine and Kim Dixon; Editing by Tim Dobbyn/
Editing by Andre Grenon)