fda glp-1 shortage list lawsuit Novo's Wegovy and Ozempic removed from US list, compounders on notice FDA ban on compounded tirzepatide:

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IC 50 = 32.5 M) (Table 1 and Supplementary Table 20)

Available: [16] C

Not recommended for children and adolescents under 18 years

Compounds such as MOTS-c, AOD9064, 5-Amino-1MQ, Semaglutide, and Tirzepatide are increasingly used in metabolic optimization and weight management strategies

The PA criteria differ by diagnosis: For Type 2 diabetes indication: Documented Type 2 diabetes diagnosis (A1C 6.5% or fasting glucose 126 mg/dL) BMI 27 kg/m (this requirement appears in most UnitedHealthcare medical policies even for diabetes, though not an FDA requirement) Trial and failure of metformin for at least 90 days, unless contraindicated Trial and failure of at least one other oral diabetes medication (sulfonylurea, DPP-4 inhibitor, or SGLT2 inhibitor) for 90 days A1C remains 7.0% despite conventional therapy For obesity indication (when covered): BMI 30 kg/m, or BMI 27 kg/m with at least one weight-related comorbidity (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) Documented weight-loss attempts with behavioral modification and diet for at least 6 months No contraindications (personal or family history of medullary thyroid carcinoma, Multiple Endocrine Neoplasia syndrome type 2) Prescriber must be MD, DO, NP, or PA (some plans require endocrinologist or bariatric specialist) The PA approval timeline is 3 to 7 business days for standard requests, 24 hours for urgent requests