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FDA committees withhold approval of oral testosterone therapy

September 19, 2014

COLLEGE PARK, MD — On day 2 of a joint meeting on testosterone replacement therapies, the Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management FDA advisory committees voted 12-8, with one abstention, that a novel oral testosterone undecanoate did show efficacy as a testosterone replacement therapy.

The panel also ruled 17-4 that the overall profile for benefits and risks of the soft-gel capsule formulation oral testosterone undecanoate (TU) Rextoro, developed by Clarus Therapeutics, did not support approval of this product for testosterone replacement therapy.
“Primary efficacy endpoint just met the success threshold,” Mark S. Hirsch, MD, of Center for Drug Evaluation and Research, FDA, said during a presentation.

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