Lipocine Reintroduces Tlando
Reading Time: 3 minutes Mar 4, 2020 Lipocine Inc.'s (LPCN) TLANDO, an oral testosterone product candidate, has been reintroduced and submitted for FDA approval, with a decision date now set for August 28, 2020. TLANDO is promoted as a testosterone replacement therapy in adult males for conditions linked to a deficiency of endogenous testosterone, also known as hypogonadism. Based on the Post Action meeting and written feedback, the FDA indicated Lipocine's approach to addressing the single remaining deficiency through the reanalysis of existing data in accordance with FDA feedback appears to be a reasonable path forward. The FDA requested that the information generated by...