Tesamorelin
Cannot be compounded.Tesamorelin is a biological product, and federal law gives compounding pharmacies and outsourcing facilities no pathway to make it. A branded tesamorelin product is licensed for one labeled use, the reduction of excess abdominal fat in adults with HIV who have lipodystrophy, and it is not for weight loss. Compounded tesamorelin is not that product and is not FDA-approved.
View the full FDA status recordPrimary sources
- FDAList of approved NDAs for biological products that were deemed to be BLAs on March 23, 2020 (corrected April 2, 2020)Document dated . Checked .
- FDACompounding and the FDA: Questions and AnswersDocument dated . Checked .
- FDA labelopenFDA drug labels: tesamorelin, BLA 022505 (EGRIFTA SV and EGRIFTA WR)Document dated . Checked .
- FDAopenFDA drugsfda: tesamorelin, BLA 022505Document dated . Checked .
- FDA warning letterWarning letter 734884, Royal Peptides LLCDocument dated . Checked .
- FDA warning letterWarning letter 735063, Peptide Partners LLCDocument dated . Checked .
- WADAWorld Anti-Doping Code, 2026 Prohibited ListDocument dated . Checked .
