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# Lipocine NDA Resubmission for Testosterone Product
- URL: https://www.fdaweb.com/lipocine-nda-resubmission-for-testosterone-product/
- Published: 2017-08-14T12:00:00.000Z
- Updated: 2026-09-14T22:41:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139378

Lipocine has resubmitted an NDA for Tlando, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone (hypogonadism). The resubmission addresses issues outlined in a 6/2016 complete response letter and provides additional information related to the dosing algorithm for the proposed label. The agency has assigned a user fee review target date of 2/18/2018.

  
The NDA is based on the results of the company’s dosing validation study, which confirmed the efficacy of Tlando with a fixed dose regimen without need for dose adjustment, according to the company. Tlando was well tolerated upon 52-week exposure with no reports of drug related serious adverse events, it says.