Endo's Testosterone Drug Denied by FDA Again

Source: PharmaManufacturing.com

Jun 03, 2013

Reuters

Endo Health Solution Inc's injectable testosterone drug Aveed has been denied approval by the Food and Drug Administrations (FDA) for the third time. The FDA has cited the need for a better plan to manage the risks associated with the drug yet again. In April, an advisory panel to th eFDA had already agreed that Endo's proposed plan for managing the risks associated with the drug was insufficient. Aveed is comprised of testosterone and castor oil and there are concerns that they oil might cause blockages in blood vessels in the lungs. Read the full story.  
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