Pharmaceutical Business review

FDA rejects Merck’s cholesterol drug

In the FDA’s letter, the agency rejected the proposed trade name Cordaptive for MK-0524A (ER niacin/laropiprant). The company said at the appropriate time it expects to pursue the alternative trade name Tredaptive for use in the US.

Peter Kim, executive vice president and president, Merck Research Laboratories, said: “We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A.”