Merck says FDA concerned about aspects of drug study

(Reuters) – Merck & Co Inc said on Monday that health regulators are concerned about operational aspects of a hypersensitivity study for sugammadex, an injection designed to reverse the effects of muscle relaxants used by anesthesiologists during surgery. Merck said on Monday it had received a “complete response letter” from the FDA on its resubmission of sugammadex for approval. Such letters typically lay out U.S. Food and Drug Administration concerns that need to be addressed before a medicine can gain approval. …