The FDA has approved two new oral formulations of testosterone undecanoate — Kyzatrex (Marius) and Tlando (Antares) — for treatment of males with a deficiency of endogenous testosterone due to conditions such as Klinefelter syndrome, orchiectomy, toxic damage from chemotherapy or alcohol, or pituitary-hypothalamic injury caused by tumors, trauma, or radiation. Jatenzo, another oral testosterone undecanoate formulation, was approved for the same indication in 2019. No testosterone products are approved for treatment of low testosterone levels due solely to...

The FDA has required changes in the labels of all testosterone products to reflect new data on their cardiovascular effects. The updated labels will no longer include a boxed warning about an increased risk of adverse cardiovascular outcomes, but will contain a new warning about an increase in blood pressure.