Despite mounting safety concerns, FDA has finally given the green light to Endo Pharmaceuticals Inc.’s long-acting injectable low testosterone treatment Aveed after three previous complete responses. While the approval is a win for the company, the Risk Evaluation and Mitigation Strategy that came with it will make the marketing of the drug more complicated in an already saturated market.
Endo Gets Surprise Aveed Approval, But REMS Could Be A Roadblock
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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