WHITEHOUSE STATION, N.J. (AP) — Merck said Monday that the Food and Drug Administration refused to approve its drug Bridion.
Bridion, or sugammadex, is used to reverse the effects of anesthesia after surgery. Merck & Co. said the drug is approved in more than 50 countries, but hasn't been cleared in the U.S. The FDA rejected the drug in 2008 because of allergic reactions and bleeding among some patients. In July the agency canceled a meeting of experts who were to review Bridion, saying it needed more time to resolve questions about one of the sites used for patient testing.
Merck said Monday that the FDA still has concerns about that study. The company said it is evaluating the FDA's response to its application for the drug.
Sales of Bridion rose 14 percent to $69 million in the second quarter.
In morning trading, shares of Merck declined 37 cents to $47.64.