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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Update on Aveed (Nebido- testosterone undecanoate- long acting testosterone)
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<blockquote data-quote="Nelson Vergel" data-source="post: 1900" data-attributes="member: 3"><p>Update on Aveed (Nebido- testosterone undecanoate- long acting testosterone):</p><p></p><p>After a few problems with the FDA review process that have slowed down its approval by 3 years, this was the last announcement:</p><p></p><p> "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 <a href="http://www.drugs.com/nda/aveed_130905.html#" target="_blank"><u>application</u><img src="https://images.intellitxt.com/ast/adTypes/icon1.png" class="bbImage" alt="" data-url="https://images.intellitxt.com/ast/adTypes/icon1.png" style="" /></a> (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."</p><p></p><p>The following map shows the countries were it is approved (in orange)</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 1900, member: 3"] 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 [URL="http://www.drugs.com/nda/aveed_130905.html#"][U]application[/U][IMG]https://images.intellitxt.com/ast/adTypes/icon1.png[/IMG][/URL] (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) [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Update on Aveed (Nebido- testosterone undecanoate- long acting testosterone)
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