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FDA Rejects Testosterone Drug for Third Time

Risks and complications cause concern (May 30)

The FDA has declined to approve Aveed (testosterone undecanoate injection; Endo Pharmaceuticals) for men with hypogonadism. The agency’s complete response letter (CRL) requested that the product’s risk evaluation and mitigation strategies (REMS) include a medication guide as well as Elements to Assure Safe Use (ETASU) to mitigate the risks and severe complications related to post-injection reactions.

According to a Reuters report, this is the third time that the drug has gotten a “thumbs down.”

In April, an FDA advisory panel voted overwhelmingly that the manufacturer’s proposed plan for managing the risks associated with the drug was insufficient, so the latest rejection comes as no surprise.

Aveed (testosterone undecanoate injection) consists of testosterone and castor oil. The FDA has expressed concern that the oil could block blood vessels in the lungs.

Sources: Endo Pharmaceuticals; May 30, 2013; and Reuters; May 30, 2013.

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