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Approved Use While tesamorelin has FDA approval, it's important to understand the regulatory framework: On-label (approved): Prescription Egrifta for HIV-associated lipodystrophy Off-label: Any use outside the approved indication (physicians may prescribe off-label, but this is not FDA-endorsed) Research use: Laboratory-grade tesamorelin for investigational purposes Compounding Regulations Because tesamorelin IS FDA-approved (unlike BPC-157 or TB-500), compounding rules differ

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23 (Suppl 3.), 1719 (2010)

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For a drug producing nearly 30% weight loss, an 11.3% discontinuation rate is the kind of trade-off most patients and most clinicians will accept

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