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MOUNJARO 5 mg and 10 mg was studied in pediatric patients 10 years of age and older with type 2 diabetes in combination with metformin and/or basal insulin [see Clinical Studies (14.5)]
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[12] Adverse effects [edit] Preclinical, phase I, and phase II clinical trials indicated that tirzepatide exhibits adverse effects similar to those of other established GLP-1 receptor agonists, such as dulaglutide (sold as Trulicity) and semaglutide (sold as Wegovy, Ozempic, and Rybelsus)
The agency sent a warning letter to Medvi, citing it for misbranding by implying that Medvi itself was the compounder and making claims that implied FDA approval of the compounded product
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