Research material and lot documents
Tesamorelin is FDA approved in one specific form: the prescription drug Egrifta, approved on November 10, 2010. The approval letter says the application "provides for the use of Egrifta" "for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy" and that the product "is approved, effective on the date of this letter." Source: FDA approval letter, November 10, 2010.
Drugs@FDA lists the application as BLA 022505, applicant THERATECHNOLOGIES, active ingredient TESAMORELIN ACETATE, marketing status Prescription. The record also gives the 2010 approval date and links the letters and labels for each supplement. Source: Drugs@FDA record for BLA 022505.
FDA's Purple Book lists three products under BLA 022505: Egrifta (marked "Disc"), Egrifta SV and Egrifta WR (both marked Rx). The proper name is tesamorelin and the applicant is Theratechnologies Inc. Source: FDA Purple Book record for Egrifta.
FDA approved a supplement for Egrifta WR on March 25, 2025. The approval letter says the supplement "provides for a new formulation" and a "new drug product manufacturing site." Source: FDA supplement approval letter, March 25, 2025.
The March 2025 label for Egrifta WR gives the indication: "EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy." Under limitations of use it also says: "EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect." Source: FDA label for Egrifta WR, revised March 2025.
Drugs@FDA states: "This Former NDA Was Deemed To Be a BLA on March 23, 2020." FDA's list of former NDAs deemed to be BLAs has a row for tesamorelin acetate: Egrifta and Egrifta SV, application 022505, Theratechnologies Inc., initial approval 11/10/2010. The list also says that the Further Consolidated Appropriations Act, 2020 removed the parenthetical "(except any chemically synthesized polypeptide)" from the statutory category of "protein."
FDA's rule at 21 CFR 600.3(h)(6) defines a protein as "any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size." The label describes tesamorelin as a 44 amino acid sequence. Sources: FDA list of approved NDAs deemed to be BLAs on March 23, 2020 and 21 CFR 600.3 definitions.
The approval records name the Egrifta products and their applicant. They do not describe other materials sold under the name tesamorelin. Curo's research-use policy states that its products are designated research use only and that its statements have not been evaluated by FDA. The page tesamorelin research material and lot records covers what a listing and a lot report show.
The identity facts behind the approval, including the sequence and formula, are on the tesamorelin peptide identity and research record.