Testosterone undecanoate oral twice-daily - Lipocine

Drug Profile

Testosterone undecanoate oral twice-daily - Lipocine

Alternative Names: ABT-SLV361; LPCN-1021; TLANDO

Latest Information Update: 05 Sep 2017

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At a glance

  • Originator Lipocine
  • Class Anabolic steroids; Androstenols; Hormonal replacements; Small molecules; Testosterone congeners
  • Mechanism of Action Androgen receptor agonists; Testosterone replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Hypogonadism

Most Recent Events

  • 17 Nov 2017 FDA assigns new PDUFA action date of 08/05/2018 for testosterone undecanoate (TLANDO™) for Hypogonadism
  • 18 Oct 2017 The US FDA schedules the Bone, Reproductive and Urologic Drugs Advisory Committee meeting on January 10, 2018 to discuss the New Drug Application for testosterone undecanoate (TLANDO™) in Hypogonadism
  • 17 Aug 2017 US FDA accepts resubmitted NDA for Hypogonadism for review
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