Apparently, the third time wasn't the charm. Last week, FDA advisory committees recommended that the agency not approve over-the-counter status for statin drug Mevacor. This is Merck's third attempt over seven years to obtain nonprescription status for Mevacor. Merck, of course, contends that consumers can safely manage statins on their own. The pharma has been touting research which suggests that three-fourths would be able to manage this regimen. But committee members weren't impressed, noting that the other one-fourth could face serious side effects. The panels' recommendations aren't final--the FDA has to decide whether to accept its conclusions--but the agency usually does. Merck isn't saying whether it will try a fourth time.
To learn more about the decision:
- read this FiercePharma piece
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