On Tuesday, January 9, 2018, the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) did not support, by a vote of 9-Yes to 10-No, with no abstentions, the safety and efficacy of Jatenzo (oral testosterone undecanoate capsules),submitted by Clarus Therapeutics, Inc. (Clarus) for the proposed indication of testosterone replacement in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

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