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Regulatory front


Friday, January 12, 2018

Instead of a thumbs up from the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee Wednesday, Lipocine Inc.'s Tlando was downed by safety concerns. While six committee members supported approval of the oral testosterone undecanoate capsule as a testosterone replacement therapy (TRT) for men with primary hypogonadism and hypogonadotropic hypogonadism, 13 panelists said the overall benefit/risk profile was not acceptable.

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