Tlando is an oral form of testosterone undecanoate and failed to achieve high enough blood testosterone levels at the recommended dosage. The article says:
The FDA has turned down Lipocine Inc.'s Tlando, an oral testosterone product candidate for testosterone replacement therapy in adult males for hypogonadism, yet again. The regulatory agency has cited the failure of the efficacy trial to meet the three secondary endpoints for maximal testosterone concentrations ("Cmax") as the reason for denying approval to Tlando.
The FDA has turned down Lipocine Inc.'s Tlando, an oral testosterone product candidate for testosterone replacement therapy in adult males for hypogonadism, yet again. The regulatory agency has cited the failure of the efficacy trial to meet the three secondary endpoints for maximal testosterone concentrations ("Cmax") as the reason for denying approval to Tlando.
