FDAnews Marketing and Sales Bulletin

The FDA Nonprescription Drugs and Endocrinologic and Metabolic Advisory committees voted 10–2 with one abstention recommending the FDA not approve Merck’s OTC-switch application for statin Mevacor.

The joint meeting was the third held to consider the Mevacor (lovastatin) switch application.

The committees also voted 11–2 that a Merck consumer self-selection study did not demonstrate that OTC consumers could appropriately make a decision on whether to take the drug.         

Eileen Craig, a reviewer for the FDA’s Division of Metabolism and Endocrinology Products, asked the committees whether they were concerned that some patients on more potent statins, such as Pfizer’s Lipitor (atorvastatin calcium) and AstraZeneca’s Crestor (rosuvastatin calcium), would switch to OTC Mevacor.
 
More than 30 percent of participants in studies supporting the switch application who already were taking lipid-lowering therapies said they thought it would be appropriate for them to take Mevacor, the FDA said. Of those subjects, 55 percent said they would replace their current lipid-lowering medication with OTC Mevacor.