Validation of Dosing Regimen of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men.

Trial Profile

Validation of Dosing Regimen of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men.

Completed
Phase of Trial: Phase I

Latest Information Update: 10 Jan 2018

At a glance

  • Drugs Testosterone undecanoate (Primary)
  • Indications Hypogonadism
  • Focus Pharmacokinetics
  • Acronyms DV
  • Sponsors Lipocine
  • Most Recent Events

    • 10 Jan 2018 According to a Lipocine media release, Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") of the U.S. Food and Drug Administration ("FDA") voted six in favor and thirteen against the benefit/risk profile of TLANDO for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
    • 17 Nov 2017 According to a Lipocine media release, the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for TLANDO for the proposed indication of testosterone replacement therapy (TRT) in adult males for conditions associated with a deficiency of endogenous testosterone (hypogonadism). The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) goal date of May 8, 2018.
    • 18 Oct 2017 According to a Lipocine media release, the U.S. Food and Drug Administration has scheduled the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) meeting on January 10, 2018 to discuss the New Drug Application (NDA) for TLANDO, for the proposed indication of testosterone replacement therapy (TRT) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
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