The FDA has approved Azmiro (Azurity), the first injectable formulation of testosterone cypionate to become available in single-dose vials and prefilled syringes for treatment of males with conditions associated with a deficiency or absence of endogenous testosterone. Injectable testosterone cypionate has been available in multidose vials (Depo-Testosterone, and generics) for many years. Testosterone enanthate (Xyosted) is available in prefilled autoinjectors for use in adult men. No testosterone products are approved for treatment of low testosterone levels due solely to aging. All testosterone products are classified as schedule III controlled substances.

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 aging.

The FDA has approved an auto-injector formulation of testosterone enanthate (Xyosted – Antares Pharma) for once-weekly subcutaneous self-administration in adult males with conditions associated with a deficiency or absence of endogenous testosterone. It is the first subcutaneous formulation of testosterone to be approved by the FDA. Xyosted is contraindicated for treatment of low testosterone levels associated with aging.