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Clarus' Jatenzo Suffers From Off-Label Concerns At US Advisory Committee

 
• By Derrick Gingery

Oral testosterone candidate loses close vote as many panelists worry that convenience could spur misuse; REMS could offer reassurance.

FDA Advisory Committee Feature image

Concerns about off-label use drove most of the votes against approval during the the US FDA's Bone, Reproductive and Urologic Drugs Advisory Committee's review of Clarus Therapeutics Inc.'s oral testosterone candidate Jatenzo (testosterone undecanoate) on Jan. 9

Many panel members were sympathetic to the need for an oral therapy for those who would fit the indication, which was replacement therapy for primary hypogonadism, both congenital and acquired, as well as hypogonadotropic hypogonadism, congenital or acquired

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