The US FDA may have to create a post-marketing plan to address concerns about off-label use of oral testosterone should it approve either Clarus Therapeutics Inc.'s Jatenzo (testosterone undecanoate) or Lipocine Inc.'s Tlando (testosterone undecanoate). The plan could include a cardiovascular outcomes trial or a risk management plan, members of the Bone, Reproductive and Urologic Drugs Advisory Committee suggested during their Jan. 9-10 review of the products.
Oral Testosterones Might Use REMS, CV Post-Market Study To Win Approval
US FDA advisory committee worries about off-label use of Lipocine's Tlando and Clarus' Jatenzo.
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