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FDA Approval Status and Prescribing Criteria Wegovy (Semaglutide 2.4 mg) The FDA approved Wegovy in June 2021 for chronic weight management in adults with a BMI of 30 or higher, or a BMI of 27 or higher with at least one weight-related condition such as hypertension, type 2 diabetes, or dyslipidemia

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Given the evidence, based on non-clinical studies, clinical trials, post-marketing surveillance and medical literature, the committee has recommended that semaglutides labels be updated to include the very rare risk, according to the Friday announcement

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