FDA rejects Merck cholesterol drug

WHITEHOUSE STATION, N.J., April 30 (UPI) -- Merck Research Laboratories says the U.S. Food and Drug Administration has rejected an application for a new cholesterol drug.

The drug MK-0524A, a combination of niacin and laropiprant, was developed to treat primary hypercholesterolemia or mixed dyslipidemia. Merck said it plans to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefits and risks of the drug.

"We firmly believe that MK-0524A provides physicians with an important option to manage their patients' cholesterol," Peter S. Kim, executive vice president and president of Merck Research Laboratories, said. "We are encouraged that on April 24, the Committee for Medicinal Products for Human Use recommended marketing approval for MK-0524A in Europe, and we will continue to pursue approval within individual markets in the EU and around the world."

The FDA also rejected the proposed trade name Cordaptive. Merck said it expects to pursue the alternative trade name Tredaptive for use in the United States.