In March 2019, after many years of refusal by the FDA and legal wrangles with its direct competition, Lipocine, Clarus Therapeutics testosterone capsule Jatenzo (testosterone undecanoate) was finally approved. This approval has meant that for the first time in over 60 years, a new oral testosterone drug has made its way to the market.
In November 2019 another new oral testosterone drug, Tlando (testosterone undecanoate) received a tentative approval from the FDA. This is not the same as the approval that Jatenzo has received as Tlando is not allowed on to the open market until March 2022 (Jatenzo has an exclusivity period which does not expire until March 2022).
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