Posted by Michael Wonder on 11 Nov 2019
Lipocine receives complete response letter for Tlando from U.S. FDA
11 November 2019 - Lipocine announced today that it has received a complete response letter from the United States Food and Drug Administration ("FDA") regarding its new drug application for Tlando, the Company's oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
The letter identified one deficiency stating the efficacy trial did not meet the three secondary endpoints for maximal testosterone concentrations ("Cmax").
The letter does not identify any specific issues relating to the chemistry, manufacturing and controls of Tlando.
