Tesamorelin
Also known as: Egrifta, TH9507
Tesamorelin is currently approved product — specific indication/route for fda-approved drug product.
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A growth hormone-releasing factor analog. FDA has approved it in Egrifta for a specific HIV-associated indication.
Current status
FDA-approved drug product: Approved product — specific indication/route; 503B outsourcing-facility compounding: Component of FDA-approved drug (Category 1**)
| Activity | Status | As of | Jurisdiction | Qualification | Sources |
|---|---|---|---|---|---|
| FDA-approved drug product | Approved product — specific indication/route | Nov 10, 2010 | United States federal | Egrifta (tesamorelin for injection) approved 2010-11-10 to reduce excess abdominal fat in HIV-infected patients with lipodystrophy. | |
| 503B outsourcing-facility compounding | Component of FDA-approved drug (Category 1**) | Mar 21, 2025 | United States federal | Sermorelin acetate is listed in 503B Category 1 as a component of an FDA-approved drug. Tesamorelin itself is an approved active ingredient; 503B compounds must also satisfy 'not essentially a copy' and other conditions. |
What this means
- ✓ FDA-approved drug product: Approved product — specific indication/route. Egrifta (tesamorelin for injection) approved 2010-11-10 to reduce excess abdominal fat in HIV-infected patients with lipodystrophy.
- ✓ 503B outsourcing-facility compounding: Component of FDA-approved drug (Category 1**). Sermorelin acetate is listed in 503B Category 1 as a component of an FDA-approved drug. Tesamorelin itself is an approved active ingredient; 503B compounds must also satisfy 'not essentially a copy' and other conditions.
What this does not mean
- ✗ Status in one jurisdiction does not automatically apply elsewhere.
- ✗ An approved active ingredient is not the same as an approved finished product.
- ✗ “Research use” labeling does not make an unapproved drug lawful for human use.
Timeline
FDA approves Egrifta
finalApproved for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
Controlling sources
- Egrifta (tesamorelin) Approval
U.S. Food and Drug Administration · Approval record · NDA 022505