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FDA rejects Endo low-T drug Aveed, again

This article was originally published in Scrip

Executive Summary

After the US markets closed on 30 May, Endo Pharmaceuticals disclosed the US FDA had rejected the company's new drug application (NDA) for its long-acting testosterone undecanoate injection Aveed as a treatment for hypogonadism, or low testosterone, a condition that affects millions of American men and is associated with erectile dysfunction and decreased sexual desire, fatigue and loss of energy, depressed mood, osteoporosis and a diminishment in the physical characteristics of a man, such as decreased body hair.

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