Reply to thread

Update on Aveed (Nebido- testosterone undecanoate- long acting testosterone):


After a few problems with the FDA review process that have slowed down its approval by 3 years, this was the last announcement:


 "Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the complete response submission made by Endo to the new drug application (NDA) for its long-acting testosterone undecanoate injection, Aveed, intended for men diagnosed with hypogonadism. In connection with the acceptance, the FDA assigned Endo's NDA a new Prescription Drug User Fee Act (PDUFA) action date of Feb. 28, 2014."


The following map shows the countries were it is approved (in orange)


Back
Top