Merck & Co. reported late Monday the U.S. Food and Drug Administration didn't approve the MK-0524A treatment or Cordaptive a cholesterol drug.
The FDA filed a not approval letter rejecting Cordaptive, as the name that was planned for the drug. However Merck is planning to submit additional information to re-evaluate the product.
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, said Peter Kim, president of Merck Research Laboratories.
Analysts expected the drug to be approved in the United States since last week the European regulators recommended the drug for the European market.
Merck confirmed its 2008 earnings outlook from $3.28 to $3.38 per share.
Shares of Merck fell 4.87 percent to $39.42 in after hours trading in the New York Stock Exchange after closing at $41.44 on Monday.