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

 
• By Sarah Karlin-Smith

FDA briefing documents for the advisory committee review of Endo’s Aveed cite the “excessive burden” imposed by any one of the REMS restrictive elements, given the injectable testosterone’s limited additional benefit compared to other available treatment options.

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.

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