Further Complete Response Letter for Aveed (Endo Pharma)
Endo Pharmaceuticals has received a third Complete Response Letter (CRL) from the FDA, asking for tighter safety measures before it can approve the application to market its long-acting testosterone injection Aveed (testosterone undecanoate) for the treatment of Hypogonadism.
The Complete Response Letter did not include requests for the company to perform additional clinical studies. The FDA outlined the steps necessary to support approval of the NDA and updated the requirement for a Risk Evaluation and Mitigation Strategy (REMS). Specifically, the FDA has requested that the REMS include a Medication Guide as well as Elements to Assure Safe Use to mitigate the risks and severe complications related to post-injection reactions.
The drug is sold as Nebido by Bayer HealthCare in some 47 markets outside the USA.
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