Theratechnologies gets March 2025 PDUFA date for tesamorelin F8 formulation sBLA

Theratechnologies (THTX) announced that the United States FDA has assigned a Prescription Drug User Fee Act goal date of March 25, 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 U.S. under the trade name EGRIFTA SV. The new formulation is patent protected in the U.S. until 2033.