Endo Pharma Says FDA Issues CRL on Aveed NDA, Says Didn't Include Request for Added Trials
Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for Endo's long-acting testosterone undecanoate injection, AVEED™, for men diagnosed with 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 (ETASU) to mitigate the risks and severe complications related to post-injection reactions.
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