Trial Profile
Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 04 Apr 2022
Price :
$35
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At a glance
- Drugs Testosterone undecanoate (Primary) ; Testosterone
- Indications Hypogonadism
- Focus Registrational; Therapeutic Use
- Acronyms SOAR
- Sponsors Lipocine
- 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.
- 28 Sep 2021 According to a Lipocine media release, the company announced that the U.S. Food and Drug Administration has affirmed the resubmission of its New Drug Application for TLANDO, will be a Class 1 resubmission. A Class 1 NDA resubmission includes a two-month FDA review goal period. Resubmission of the NDA is a necessary requirement to receive final approval from the FDA and is expected to occur on January 28, 2022, based on the FDA's Class 1 affirmation.