Theratechnologies (THTX) said Tuesday that the US Food and Drug Administration assigned a Prescription Drug User Fee Act goal date of March 25 for the supplemental biologics license application for F8 formulation of tesamorelin.
The company said it plans to replace the F4 formulation, or Egrifta SV, with the F8 formulation once approved by the FDA.
The new formulation is protected by a patent until 2033 in the US, the company added.
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