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# Theratechnologies ‘Complete Response’ on Tesamorelin
- URL: https://www.fdaweb.com/theratechnologies-complete-response-on-tesamorelin/
- Published: 2024-01-24T12:00:00.000Z
- Updated: 2026-09-14T14:21:05.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156204

FDA has issued Theratechnologies a complete response letter on its supplemental BLA for a F8 formulation of Egrifta SV *(*tesamorelin), indicated for reducing excess abdominal fat in adults with HIV and lipodystrophy. The company says the letter cited issues related to chemistry, manufacturing and controls concerning the microbiology, assays, impurities and stability for both the lyophilized product and the final reconstituted product. Additionally, the agency reportedly requested further information to understand the potential impact of the proposed formulation on immunogenicity risk.

Theratechnologies notes that the concerns communicated in the letter do not apply to the currently approved F4 formulation of tesamorelin. It further says it will respond to FDA’s concerns and continue to pursue approval of the newer therapeutic formulation.