FDA approves Clarus' oral testosterone replacement therapy

Clarus said FDA approved Jatenzo testosterone undecanoate for testosterone replacement therapy in adult males for primary hypogonadism and hypogonadotropic hypogonadism, which are conditions associated with a deficiency or absence of endogenous testosterone.

Clarus Therapeutics Inc. (Northbrook, Ill.) resubmitted Jatenzo's NDA in 2017 (see "Clarus Resubmits NDA for Oral Testosterone Replacement Therapy Jatenzo")...