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FDA to discuss status of Mevacor


ROCKVILLE, Md. The proposed switch of Merck’s Mevacor statin (lovastatin) is on the Food and Drug Administration advisory committee meeting docket again, according to a report published by the Tan Sheet Monday morning citing FDA documents submitted for publication in Tuesday’s Federal Register.

According to the report, the agency’s nonprescription drugs and endocrinologic and Metabolic drugs committees will meet Dec. 13 in Silver Spring, Md.

FDA advisory committees have twice before voted against switching Mevacor to OTC status, most recently criticizing a patient’s ability to adequately self-select use for a condition with no acute symptoms.

Another Merck statin, Zocor (simvastatin), has already gained behind-the-counter status in the United Kingdom, whereby a U.K. pharmacist must consult with a patient on the use of Zocor Heart-Pro before dispensing the medicine.

The FDA is hosting a separate meeting Nov. 14 to discuss a potential BTC status in the United States.

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