10 December 2024 - Theratechnologies today announced that the US FDA has assigned a PDUFA goal date of 25 March 2025 to the Company’s recently submitted supplemental biologics license application for the F8 formulation of tesamorelin.

If approved by the FDA, the F8 formulation is intended to replace the F4 formulation, which is sold in the US under the trade name Egrifta SV. The new formulation is patent protected in the US until 2033.

Read Theratechnologies press release