REMS Can’t Help Endo’s Aveed – Won’t Address Unpredictable Safety Events, FDA Advisors Say
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.
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After seven years of rejection, Endo finally gets FDA’s go-ahead on its long-acting testosterone treatment, but a strict REMS program and plenty of market competitors will make the drug’s launch difficult.
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