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This dual action targets adipose tissue directly through the beta-3 adrenergic receptor pathway

In their guidance, CMS noted that: [i]f this same [otherwise-excluded Part D] drug also receives FDA approval to treat diabetes - or reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight, then it would be considered a Part D drug for those specific uses only

In the pediatric clinical study, pediatric patients with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia compared to the adults in studies with type 1 diabetes [see Adverse Reactions (6.1)]

Where Are the Active Pharmaceutical Ingredients (APIs) Sourced From

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