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Testosterone Replacement Drug Aveed Gets U.S. Approval

Update Date: Mar 07, 2014 10:13 AM EST

Drugmaker Endo Pharmaceuticals said Thursday that it received approval from the country for its long-acting testosterone injection Aveed. The drug Aveed joins an already crowded market of hormone-boosting drugs that aim at aging American men. 

According to Irish drugmaker, the Food and Drug Administration (FDA) approved Aveed for men with low testosterone which is often associated with weight gain, fatigue and low libido. 

"Today's FDA approval of AVEED is a significant milestone for Endo. AVEED expands our branded portfolio of men's health products and highlights our passion and commitment to providing high quality therapies that improve patient care," said Rajiv De Silva, president and chief executive officer of Endo, to the Wall Street Journal. 

"With AVEED, Endo can now offer men living with hypogonadism different treatment options to raise testosterone levels. We are focused on getting AVEED to market to ensure that appropriate patients have access to it."

Earlier this year in January, the FDA issued a statement asserting that it was reviewing the drugs after a federal study of around 45,000 patients suggesting that testosterone therapy could increase the risk of heart attack in men 65 and older. 

The approved drug's injection is to be taken once every 10 weeks. The company added that it is expecting to launch the drug this month.

"Men's Health Network is pleased to see the FDA approval of a new treatment for hypogonadism as we believe men with this condition should have access to a broad range of treatment options," said Ana Fadich, MPH, vice president of the Men's Health Network, according to Tech Times. 

"Men diagnosed with hypogonadism and their partners need to have an open discussion, with each other and the man's doctor, about the condition and ways to manage it so they can find the right treatment that best suits their individual needs."

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