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Monday, Sep 23
FDA raises concerns over Merck drug study
- 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)