Oral Testosterones Might Use REMS, CV Post-Market Study To Win Approval

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.

Of the two sponsors, Clarus seemed the most prepared for that contingency, telling the committee about its post-marketing surveillance and outreach plan to help track and limit improper use, but given that the panel voted against both products, a post-market