Lipocine Inc.'s oral testosterone replacement therapy Tlando (testosterone undecanoate) was unable to overcome concerns about cardiovascular risk before the US FDA's Bone, Reproductive, and Urologic Drugs Advisory Committee, as the panel voted 13-6 on Jan. 10 that the drug's overall benefit/risk profile does not support approval.
Lipocine's Tlando Falls Short At US FDA Advisory Cmte Over Blood Pressure Concerns
Oral testosterone's current clinical data could not definitely exclude elevated blood pressure, panelists vote.
