Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Merck & Co has received a not approvable action letter from the FDA for the company's new drug application for MK-0524A for the treatment of primary hypercholesterolemia or mixed dyslipidemia.
Subscribe to our email newsletter
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.”