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FDA committees withhold approval of oral testosterone therapy

September 19, 2014

Read the Perspective from Abraham Morgentaler, MD, FACS

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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Meeting News Coverage

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…
FDA News Perspective

FDA committees near-unanimous on need to investigate testosterone therapies

September 18, 2014
COLLEGE PARK, MD — Two FDA advisory committees voted 20-1 in favor of revising the current indication for testosterone replacement therapies…
figure FDA News Perspective

Advisory Committee recommends approval of PTH therapy for hypoparathyroidism

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After a debate-filled meeting today, the Endocrinologic and Metabolic Drugs Advisory Committee voted 8 to 5 in favor of approval for recombinant…
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