Merck & Co. on Friday said the Food and Drug Administration rejected its application to market an over-the-counter cholesterol drug.
The FDA indicated that a 20 milligram dose of Mevacor OTC, or lovastatin, would require a revised label and additional data to obtain approval. Merck said it is evaluating its response, and indicated it will continue to push for clearance of Mevacor OTC.
The FDA has been reviewing a non-prescription 20 milligram dose of Mevacor since 1999, according to Merck. The FDA issued similar "not approvable" actions in 1999 and 2000.
It was another setback for Merck, whose Vytorin — the popular cholesterol drug it sells with Schering-Plough Corp. — has had its effectiveness questioned in recent weeks. The FDA held a press conference Friday to discuss its review of Vytorin.