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A bioequivalence study assessing the new formulation F8 compared to the original formulation F1 of tesamorelin

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Trial Profile

A bioequivalence study assessing the new formulation F8 compared to the original formulation F1 of tesamorelin

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 09 Feb 2024

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At a glance

  • Drugs Tesamorelin (Primary)
  • Indications HIV-associated lipodystrophy syndrome
  • Focus Pharmacokinetics

    • Most Recent Events

    • 06 Feb 2024 According to a Theratechnologies media release, the company has received the Complete Response Letter issued by the U.S. Food and Drug Administration in response to the Companys supplemental Biologics License Application for the F8 formulation of tesamorelin.
    • 23 Jan 2024 According to a Theratechnologies media release, the company has received correspondence from the U.S. Food and Drug Administration (FDA) regarding the Company's supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin.
    • 25 Sep 2023 According to a Theratechnologies media release, company expects to receive an acknowledgment letter of the sBLA application within 30 days along with a Prescription Drug User Fee Act (PDUFA) goal date.

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