Endo Pharmaceuticals announced that the FDA has accepted for review its Complete Response submission to the New Drug Application (NDA) for AVEED (testosterone undecanoate), a long-acting injection intended for men diagnosed with hypogonadism.
In May 2013, Endo was issued a Complete Response Letter regarding the NDA for AVEED. The complete response letter did not include requests for the company to perform additional clinical studies.
However, the FDA did update the requirement for a Risk Evaluation and Mitigation Strategy (REMS). The FDA specified that the REMS should include a Medication Guide and Elements to Assure Safe Use (ETASU).
The FDA has assigned Endo’s NDA a new Prescription Drug User Fee Act (PDUFA) action date of February 28, 2014.
For more information call (800) 462-ENDO or visit Endo.com.