FDA HALCION REVIEW IS EXAMINING AT LEAST TWO NEW ALLEGATIONS

Executive Summary

FDA HALCION REVIEW IS EXAMINING AT LEAST TWO NEW ALLEGATIONS raised in an investigative report that resulted from a December 1991-March 1992 inspection of Upjohn's facilities. The agency said it will evaluate the entire report but focus on what information appears to be new, such as allegations from the FDA investigators' establishment inspection report (EIR) that Upjohn misrepresented data to gain approval for use of Halcion beyond 14 days and that Upjohn hid from FDA the death of a patient taking Xanax (alprazolam) during clinical development.