FDA panel not recommending OTC use of Mevacor.
December 17, 2007
A FDA advisory panel voted against recommending the approval of OTC use of Merck’s cholesterol-lowering drug Mevacor (Lovastatin).
The recommendation was made Thursday night by a joint panel of the FDA’s Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee.
Panel members expressed concerns that too many people who were not the right candidates for the medicine, and would likely not benefit from it, would buy the drug if it was made available without a prescription.
The FDA is not bound by the committee’s recommendation, but the agency typically flows the advice of its committee. A final vote of Merck’s request is expected by Jan. 26.
[via Philadelphia Business Journal]
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