Endo’s Testosterone REMS, Revised Dosing Don’t Solve FDA Concerns

FDA appears unconvinced that Endo Pharmaceuticals Solutions Inc.’s proposed Risk Evaluation and Mitigation Strategy and new labeling instructions can alleviate the safety concerns that have previously derailed the company’s Aveed (testosterone undecanoate), leaving the company’s third attempt to win approval for the long-acting injectable testosterone in question as the review by the Reproductive Health Drugs and the Drug Safety and Risk Management advisory committees approaches.

At the April 18 joint meeting, the committees will weigh in on whether Aveed is safe for intramuscular injection for the replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone despite reports of severe post-injection reactions in clinical studies and postmarketing experience