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Fortunately, its a pretty stress-free procedure

One violation involved a failure to report a serious adverse event experienced by a patient who had taken a compounded version of semaglutide, the chemical name for the Wegovy weight loss medication sold by Novo Nordisk, according to an FDA inspection report of the Los Alamitos, Calif., facility last May and June

Unlike data exclusivity, ODE is market exclusivity, meaning the FDA cannot approve a competing drug for the same orphan indication during this period