5/31/2013 8:30:31 AM
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The Food and Drug Administration has for the third time refused approval to Endo Health Solutions Inc's injectable testosterone drug Aveed, pressing for a still better plan to manage the risks associated with the drug. The denial comes as no surprise after an advisory panel to the FDA overwhelmingly agreed in April that Endo's proposed plan for managing the risks associated with the drug was insufficient. Testosterone, a hormone produced in the testicles, is responsible for maintaining muscle bulk, bone growth and sexual function. Lack of testosterone can lead to loss of libido, depression, decreased muscle mass and fatigue.
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