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
Clarus' Jatenzo Suffers From Off-Label Concerns At US Advisory Committee
Oral testosterone candidate loses close vote as many panelists worry that convenience could spur misuse; REMS could offer reassurance.
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