As expected, regulators in the USA have rejected Merck & Co’s bid to get the green light for an over-the-counter version of its cholesterol-lowerer Mevacor.

The company has received a not approvable letter from the US Food and Drug Administration to its New Drug Application for Mevacor OTC (lovastatin) 20mg. The agency says it would require a revised label and additional data from Merck in order to back the drug to be made available on a non-prescription basis.

Edwin Hemwall, vice president of global OTC regulatory and scientific affairs at Merck, said that the firm is “evaluating the conditions outlined in the agency's response to determine a path forward for Mevacor OTC," but it is hard to see what that path could be. The FDA’s decision came as no surprise, seeing as how a joint panel of the Nonprescription Drugs and the Endocrinologic and Metabolic Drugs Advisory Committee voted 10-2 against it in December.

Furthermore, the agency’s letter is the same response that the New Jersey-based drugmaker has received in two previous bids to get approval for Mevacor OTC. A similar application was made in January 2005 with then-partner Johnson & Johnson and this followed another unsuccessful bid in 2000 to sell an OTC 10mg version of the drug.

The FDA feels that the studies supporting the latest file failed to show that patients can make appropriate assessments about whether they require a cholesterol-lowering drug. The decision is a blow not only to Merck but also to GlaxoSmithKline which last month acquired exclusive OTC marketing rights in the USA for Mevacor.