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Lipocine's Tlando Falls Short At US FDA Advisory Cmte Over Blood Pressure Concerns

 
• By Michael Cipriano

Oral testosterone's current clinical data could not definitely exclude elevated blood pressure, panelists vote.

Drugs and pills in the shape of a human heart.

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.

The overwhelming concern was specifically related to elevated blood pressure related to the drug, a risk which the panelists felt

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