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FDA refuses Merck & Co's OTC Mevacor NDA

The FDA joint panel votes against approving the OTC sales of Merck & Co's cholesterol lowering drug Mevacor 20 mg

The FDA joint panel of the Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted against approving the OTC sales of Merck & Co's cholesterol lowering drug Mevacor (lovastatin) 20 mg.

The FDA is not bound by the committee's recommendation, but takes its advice into consideration. The anticipated action date by the FDA is 26 January 2008.

UK-based pharmaceutical company GlaxoSmithKline (GSK) and Merck & Co entered into an agreement for the OTC marketing rights for Mevacor in November 2007. 

Mevacor was launched on the US market back in 1987, while the regional patent expired in 2001. The drug posted sales of around USD 20m in FY06.

The FDA rejected a similar OTC marketing request in 2005. Merck & Co argued then that OTC Mevacor could help unmedicated patients with moderate risk of heart disease.

17th December 2007

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