Validation of Dosing Regimen of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men
Latest Information Update: 04 May 2022
At a glance
- Drugs Testosterone undecanoate (Primary)
- Indications Hypogonadism
- Focus Registrational; Therapeutic Use
- Acronyms DV
- Sponsors Lipocine
- 01 May 2022 Results assessing efficacy and safety of a novel oral testosterone undecanoate therapy for the treatment of hypogonadism published in the Andrology
- 29 Mar 2022 According to a Lipocine media release, the U.S. Food and Drug Administration ("FDA") has approved TLANDO (testosterone undecanoate), in adult males with hypogonadism.
- 03 Feb 2022 According to a Lipocine media release, the U.S. Food and Drug Administration has accepted its New Drug Application resubmission for TLANDO (testosterone undecanoate). The FDA designated the NDA as a Class 1 resubmission with a two-month review goal period and set a target action date of March 28, 2022, under the Prescription Drug User Fee Act (PDUFA). Lipocine licensed the exclusive U.S. rights for TLANDO to Antares Pharma.