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Category 1 Adequately nominated, potentially eligible, and not identified in another category FDA generally states it does not intend to take action when all conditions in its interim policy are satisfied Category 2 Adequately nominated, but FDA identified potential significant safety risks Not covered by the Category 1 enforcement-discretion policy Category 3 Nominated without enough supporting information for FDA to evaluate Not covered by the Category 1 enforcement-discretion policy Two cautions matter: First, Category 1 is not the same as FDA approval

A: It may be used in medically supervised settings, but it is primarily studied for weight management

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