Philippine FDA warns against unregistered tesamorelin 10 mg injection
Post-marketing surveillance found the GHRH analog and its bacteriostatic water diluent lack a Certificate of Product Registration, leaving quality, safety and efficacy unverified.
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By Daniel Okafor · Regulatory Correspondent
Sep 26 04:27 ETSource: fda.gov.ph
The wire
- 01FDA Advisory No. 2026-1263 warns the public against buying or using unregistered Tesamorelin 10 mg lyophilized powder for injection sold with 10 mL bacteriostatic water containing 0.9% benzyl alcohol.
- 02Tesamorelin is a growth-hormone secretagogue readers follow closely, and the advisory shows unregistered vials circulating through channels outside pharmacy oversight.
- 03Under Republic Act No. 9711, distributors face sanctions; local government units and law enforcement were asked to keep the product off shelves, and adverse reactions can be reported through the agency's portal.
From the source
Read at fda.gov.phFDA Advisory No.2026-1263 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product “Tesamorelin 10 mg (Tesamorelin acetate, GHRH analog) Lyophilized Powder for Injection for Subcutaneous Use Only and Bacteriostatic W
The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:
