US advisers reject Merck non-prescription drug

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A U.S. advisory panel on Friday urged regulators to reject over-the-counter sales of Merck & Co. Inc.’s cholesterol-lowering drug Mevacor.

Merck’s research did not provide assurance that patients would use the drug safely without seeing a doctor for a prescription, the panel said in voting 20-3 against approval.

The U.S. Food and Drug Administration usually follows the recommendations of its advisory panels.

Merck and Johnson & Johnson have applied to sell an over-the-counter, low-dose version of Mevacor, part of the statin family of drugs used to lower cholesterol and heart disease risk.

The panel agreed the population Merck wanted to target would be helped by the 20-milligram Mevacor dose but was concerned pregnant women might take the drug or otherwise healthy people would expose themselves to side affects such as rare cases of muscle and liver damage.

Mevacor, which is sold generically as lovastatin, lost patent protection in 2001. Sales of brand-name Mevacor were $31 million in 2003, Merck spokesman Tony Plohoros said.

The FDA had rejected earlier proposals for nonprescription Statins from Merck and others, most recently in 2000.

Merck stock fell from $30.93 a share just ahead of the advisory panel’s decision to $30.81 in late afternoon trading.

Bristol-Myers Squibb Co. also has said it wants to sell an over-the-counter form of its statin, Pravachol. 

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