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March 29, 2022March 29, 2022 – The FDA has approved TlandoTM (testosterone undecanoate), made by Antares Pharma, for testosterone replacement therapy (TRT). Tlando is the first oral TRT on the U.S. market that does not require dose titration.
- Indicated for use in adult males, Tlando is approved to provide TRT for conditions associated with a deficiency or absence of endogenous testosterone.
- Primary hypogonadism (congenital or acquired).
- Hypogonadotropic hypogonadism (congenital or acquired).
- Tlando is only intended for individuals who have hypogonadal conditions associated with structural or genetic etiologies, as it carries a risk of blood pressure increases that can heighten the risk of major cardiovascular (CV) events, including CV death.
- The recommended dosing is 225mg taken by mouth twice daily with food.
- Tlando has launched at a wholesale acquisition cost (WAC) of $695 for 120 capsules.