FDA reviewing Lipocine's resubmitted NDA for oral testosterone replacement

Lipocine Inc. (NASDAQ:LPCN) said FDA accepted its resubmitted NDA for Tlando testosterone undecanoate (LPCN 1021) as testosterone replacement therapy in men with hypogonadism. Its PDUFA date is Feb. 8, 2018.

Last year, FDA issued a complete response letter identifying problems with the company’s proposed dose titration scheme for clinical practice, which “significantly differed” from the scheme used in a Phase III trial (see BioCentury, July 11, 2016). ...