Pharmaceutical Product Guide » testosterone undecanoate injection http://www.pharmaceuticalproductguide.com/blog A comprehensive guide to pharmaceutical products for medical professionals Fri, 11 Jun 2010 09:15:33 +0000 http://wordpress.org/?v=2.8.2 en hourly 1 Endo Pharmaceuticals Provides Regulatory Update on AVEED(TM) Injection http://www.pharmaceuticalproductguide.com/blog/2009/12/24/endo-pharmaceuticals-provides-regulatory-update-on-aveedtm-injection/ http://www.pharmaceuticalproductguide.com/blog/2009/12/24/endo-pharmaceuticals-provides-regulatory-update-on-aveedtm-injection/#comments Thu, 24 Dec 2009 06:36:57 +0000 Kimberly O'Brien http://www.pharmaceuticalproductguide.com/blog/?p=180 Endo PharmaceuticalsEndo Pharmaceuticals has announced that it received a complete response letter from the FDA regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection, AVEED(TM), for men diagnosed with low testosterone. Low testosterone is also known as hypogonadism. In the complete response letter, the FDA has requested information from Endo to address the agency’s concerns regarding very rare but serious adverse events, including post-injection anaphylactic reaction and pulmonary oil microembolism.

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