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FDA Denies Approval To Endo Health Solutions Inc's Testosterone Drug Again


Thursday, 30 May 2013 05:32pm EDT 

Reuters reported that The U.S. 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. 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. Aveed is made of testosterone and castor oil and the FDA has previously expressed concern of a risk that the oil could cause blockages in blood vessels in the lungs. Lack of a suitable strategy to address these issues had led the FDA to refuse Aveed's marketing application the last two times. 

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