WHITEHOUSE STATION, N.J. -- Merck & Co. says the Food and Drug Administration needs more information on its cholesterol drug candidate Cordaptive, but the pharmaceutical company is reaffirming its profit guidance despite the setback.
The FDA issued a "not approvable" action letter for the drug also known as MK-0524A, and it also rejected the proposed trade name Cordaptive. Merck says it may use the name Tredaptive in the U.S.
Peter Kim, president of Merck Research Laboratories, said Monday that the company plans to submit additional information to the FDA so it can "further evaluate the benefit/risk profile of MK-0524A."
Merck also reaffirmed its 2008 earnings forecast $3.28 to $3.38 per share. Merck shares were up in regular trading but are now down 4.8%. <<
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