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355(j)(5)(B)(iv)
Semaglutide is an FDA-approved weight loss medication that has revolutionized treatment for thousands worldwide
Compounded medications are considered only when a practitioner determines that an FDA-approved medication is not appropriate for a patients specific medical needs and that a customized formulation may be appropriate
The reduction in BMI for those receiving tirzepatide and other incretin-based therapies is substantial but is not instantaneous
While the Phase 2 trial did not specifically stratify outcomes by baseline eGFR, GLP-1 receptor agonists as a class have demonstrated renoprotective effects in at-risk populations

Lightheadedness, tremor, confusion, and sweating are warning signs