Tesamorelin
EGRIFTA WR
EGRIFTA WR is an FDA-approved tesamorelin prescription product for one defined HIV-lipodystrophy use. Its label explicitly says it is not indicated for weight-loss management.
The approved product is tied to a specific indication and presentation.
The FDA Purple Book anchors the licensed biologic record.
The label describes reduction of excess abdominal fat in a defined adult population.
The current label says the product is not indicated for weight-loss management.
Resolve the application before the claim.
- Brand
- EGRIFTA WR
- Active ingredient
- Tesamorelin
- US application
- BLA 022505
- Company named in current label
- Theratechnologies Inc.
- Dosage form
- Lyophilized powder kit
- Route
- Subcutaneous
- Approval record
- Tesamorelin BLA first approved in 2010
- Label record updated
- March 2025
What this approval covers - and what it does not.
This summary stays intentionally high level. Use the current full prescribing information for complete warnings, contraindications, adverse reactions, and instructions.
The exact approved record
The current US label covers reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. The label says it is not indicated for weight-loss management and that long-term cardiovascular safety has not been established.
Open current label ↗An ingredient match is not product equivalence
This record describes EGRIFTA WR under BLA 022505. The current label says EGRIFTA WR and EGRIFTA SV are not substitutable. Seller-labelled tesamorelin research vials do not inherit either approved product's evidence, manufacturing review, presentation, or label.
Read the category guide →EGRIFTA WR across 42 countries.
This record starts with the exact US FDA medicine identity. The global and state maps keep authorization, presentation, prescription route, market status, pharmacy, and seller records separate.
Compare EGRIFTA WR by country →Compare EGRIFTA WR by US state →The questions behind the medicine search.
Answers are based on the dated FDA and DailyMed records below. They are educational reporting, not a diagnosis, prescription, or treatment recommendation.
Is Egrifta WR approved for general weight loss?
No. The current label explicitly says EGRIFTA WR is not indicated for weight-loss management. Its approved use is reduction of excess abdominal fat in HIV-infected adults with lipodystrophy, and the label also notes that long-term cardiovascular safety has not been established.
Are Egrifta WR and Egrifta SV interchangeable?
The current prescribing information says they are not substitutable. Product form and label are part of the approved identity, so the shared active ingredient does not erase presentation-specific differences.
Does an online tesamorelin vial share Egrifta's approval?
No. A research-market listing using the tesamorelin name is not EGRIFTA WR or EGRIFTA SV. FDA approval belongs to the licensed product and its exact manufacturing, presentation, supply, and label record.
Use the current full prescribing information and a licensed clinician or pharmacist for medicine-specific decisions. Do not substitute a research product, investigational program, or unapproved seller listing for an FDA-approved product.
Open safety and verification resources →