FDA panel considers nonprescription sale of Mevacor
An FDA panel was set to decide on Friday whether they will recommend approval for Merck's plan to sell a cholesterol-lowering medicine on drugstore shelves without a prescription, Reuters reported.
Allowing Merck's Mevacor to be sold over the counter would be a major shift.
Merck and Johnson & Johnson are seeking Food and Drug Administration permission to sell a nonprescription, low-dose version of Mevacor that would cost about $1 a day. The drug is a statin, one of the prescription medicines used by millions to reduce cholesterol and heart attack risk. Heart disease is the leading killer of Americans.
The advisory panel is expected to vote on Friday afternoon whether to recommend the FDA approve Merck's plan. The FDA will make the final decision, but the agency usually follows the guidance of its panels.
The FDA rejected earlier proposals for nonprescription statins from Merck and others, most recently in 2000.
Merck aims to market Mevacor to an estimated 20 million Americans who have about a 10 percent to 20 percent chance of a heart attack during the next 10 years.