FDA requests delay on Merck application for cholesterol drugs

BOSTON The Food and Drug Administration has recommended that Merck wait until it finishes clinical trials of the cholesterol drugs MK-0524A and MK-0524B before re-filing a marketing application for them, Merck announced Friday.

The FDA rejected Merck’s application for the two drugs in April, and the FDA has advised that it should wait until it receives results from the clinical trial before re-filing.

MK-0524A is a combination of the drug Cordaptive and niacin; MK-0524B combines those ingredients with Zocor. Merck has said it does not plan to seek approval for MK-0524B until it completes the application for MK-0524A.