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.
"We are encouraged by the feedback received from the FDA in the complete response and appreciate the clarity around the path forward for AVEED," said Ivan Gergel , executive vice president of research and development and chief scientific officer of Endo Health Solutions. "We plan to submit a complete response by the end of the third quarter of 2013. We look forward to making this treatment option available to appropriate male patients in the U.S. diagnosed with hypogonadism."
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