WASHINGTON (March 6, 2014) Endo Pharmaceuticals says it has received approval from federal regulators for its long-acting testosterone injection Aveed, which joins a crowded field of hormone-boosting drugs for men.
The Irish drug maker said the U.S. 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 intended to be administered once every 10 weeks, and is an alternative to weekly or biweekly dosing for older products.
The FDA approval comes as the scrutiny of popular testosterone drugs grows.
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.