- The FDA has raised concerns about the operational aspects of a hypersensitivity study that Merck (MRK) carried out for its sugammadex sodium injection for the reversal of neuromuscular blockade, which is used in anesthesiology to relax the muscles during surgery.
- The FDA noted its concerns in a Complete Response Letter to Merck's resubmission of a New Drug Application for sugammadex. The agency canceled the discussion of the treatment at a meeting of an advisory committee in July.
- Merck sells Sugammadex in over 50 countries other than the U.S., with 5M vials having been sold as of June 2013. (PR)
FDA raises concerns over Merck drug study
Sep 23 2013, 08:25 ET