Endo Pharmaceuticals Inc., a
subsidiary of Endo Health Solutions Inc. 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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