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Oral Testosterone Therapies Face Clinical Practice Difficulties, Advisory Panels Suggest

14 Jan 2018

• By Michael Cipriano

FDA's advisory committee voted down Lipocine's Tlando and Clarus' Jatenzo based on concerns about off-label use, but if they do reach the market, Tlando's lack of titration could pose problems for physicians, while both drugs could raise difficulties with the types of tubing used to test testosterone concentrations.

Back-to-back US FDA advisory committee panels for testosterone products have resulted not only in two recommendations against approval, but also spotlighted the difficulties of using such therapies in clinical practice.

The Bone, Reproductive and Urologic Drugs Advisory Committee voted Jan. 9 and Jan. 10 that Clarus Therapeutics Inc.'s Jatenzo...