Merck: No new safety concerns cited by FDA

The U.S. Food and Drug Administration will not complete its review of Merck & Co's experimental medicine to reverse the effects of anesthesia until the second half of 2013, representing a three-month delay, Reuters ctied the drugmaker as saying. Merck acquired the product, called sugammadex, through its merger in 2009 with Schering-Plough Corp. The product has faced numerous regulatory delays but is deemed by many analysts and doctors to be one of the biggest advances in anesthesia in decades. The FDA in 2008 said it could not approve sugammadex until Merck provided more clinical trial data related to allergic reactions and blood clots, possible side effects of the drug. Merck early this year said it had completed the necessary trials and that the FDA had accepted the company's resubmitted marketing application for the drug. Merck spokeswoman Pam Eisele on Friday said the FDA, in notifying the drugmaker about the expected delay in making a decision on the drug, did not cite any new safety issues. 'We've maintained regular meetings and discussions with the FDA, with a commitment to making sugammadex available in the United States,' she said.