Merck and Bristol-Myers Squibb have both had applications to market a statin for over-the-counter use turned down in the United States. The applications were rejected by Food and Drug Administration advisory committees.
Merck had applied for an OTC licence for a 10mg strength of lovastatin. The company says that it was asked for more information "to demonstrate consumers' ability to use the product with minimal instructions." It adds that the FDA committee agreed that lovastatin 10mg was safe in the eligible population.
Merck had asked the FDA to approve OTC use for patients who were believed to be at risk of heart disease because of elevated cholesterol but who were not eligible to receive cholesterol-lowering medication under the current guidelines.
Bristol-Myers Squibb had requested an OTC licence for pravastatin 10mg. The company said that the FDA advisory committee had not expressed concerns about safety but had asked for additional information, particularly in terms of defining the target population.