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Endo Gets U.S. Approval for Long-Acting Testosterone

By Associated Press – Mar 6, 2014 at 4:43PM

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The FDA approval comes amid growing scrutiny of popular testosterone drugs.

Drugmaker Endo International says it received U.S. approval for its long-acting testosterone injection Aveed, which joins a crowded field of hormone-boosting drugs for men.

The Irish drugmaker said the Food and Drug Administration approved the drug to treat men with low testosterone, which is often associated with fatigue, weight gain and low libido. Endo's injection is to be taken once every 10 weeks, versus weekly or biweekly dosing for older products.

The FDA approval comes amid growing scrutiny of popular testosterone drugs.

In January the FDA said it was reviewing the safety of the drugs after a 45,000-patient study suggested testosterone therapy could double the risk of heart attack in men 65 and older. Last month the consumer advocacy group Public Citizen called for a bold warning on the drugs.

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