Reuters: Regulatory News: CORRECTED-Merck says FDA concerned about aspects of drug study

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CORRECTED-Merck says FDA concerned about aspects of drug study Sep 23rd 2013, 12:42 Mon Sep 23, 2013 8:42am EDT Sept 23 (Reuters) - Merck & Co Inc said on Monday that health regulators are concerned about the operational aspects of a hypersensitivity study for sugammadex, an injection designed to reverse the effects of muscle relaxants used during surgery. In July, the U.S. Food and Drug Administration canceled a meeting of outside advisers who were scheduled to vote on whether to recommend the drug for approval. Merck said then the FDA needed more time to assess the results of an inspection of a clinical trial site. In 2008, the FDA declined to approve sugammadex, citing concerns about its possible association with allergic reactions and bleeding. Merck said on Monday it had received a "complete response letter" from the FDA on its resubmission of the drug for approval. Merck said it was evaluating the letter and "expects to be able to determine a path forward in the very near future." (Reporting by Caroline Humer; Editing by Jeffrey Benkoe)

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