14 May 2019 - Lipocine today announced that the U.S.FDA has accepted its new drug application for Tlando as testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The FDA has assigned 9 November 2019 as the Prescription Drug User Fee Act goal date.

In 2018, approximately 7.2M scripts were written for non-oral TRT. An easy to use non-invasive oral TRT option has benefit over topicals due to no risk of accidental testosterone transference. Tlando is designed as a fixed dose oral TRT. Research suggests that a fixed dose TRT regimen may be a preferred regimen by payers, patients, and prescribers. Tlando and long acting Tlando XR are part of Lipocine's TRT franchise of development candidates.

The NDA incorporates data compiled by Lipocine in order to address deficiencies identified by the FDA in a complete response letter to the Company in 2018 and discussed in the Post Action Meeting with the FDA.

Read Lipocine press release