An experimental cholesterol drug developed by Merck & Co. has been rejected by the U.S. Food and Drug Administration.
In issuing the "not approvable" letter, the agency said Monday that it needed more information about Cordaptive, also known as MK-0524A. The FDA also rejected Cordaptive as a brand name for the drug, the Associated Press reported.
The drug lowers bad (LDL) cholesterol and raises good (HDL) cholesterol, according to Merck officials, who said they'll make another application for FDA approval of the drug, but under the brand name Tredaptive.
"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate" the drug, Peter S. Kim, president of Merck Research Laboratories, said in a prepared statement, the AP reported. "We firmly believe that MK-0524A provides physicians with an important option to manage their patients' cholesterol."
Last week, an advisory committee recommended that European countries approve the drug, Merck noted.