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REMS Can’t Help Endo’s Aveed – Won’t Address Unpredictable Safety Events, FDA Advisors Say

 
• By Sarah Karlin-Smith

Without predictive factors to determine who is likely to get a severe post-injection reaction, FDA advisory committees say Endo’s proposed REMS for its long-acting testosterone is unlikely to allay safety concerns.

Without an understanding of what causes severe post-injection reactions with Endo Pharmaceuticals Solutions Inc.’s long-acting injectable testosterone Aveed, risk management interventions like the proposed Risk Evaluation and Mitigation Strategy will not be able to sufficiently address the safety issue, FDA’s Reproductive Health Drugs and Drug Safety and Risk Management advisory committees said April 18.

The elements of Endo’s risk management proposal “make sense clinically, but I’m not sure doing these things will ameliorate [the injection site] reactions. The reactions seem unpredictable,” Bart Clarke, Mayo...

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• By Bridget Silverman

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• By Sue Sutter

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More from North America

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

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• By Sarah Karlin-Smith

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• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.