The U.S. Food and Drug Administration approved Antares Pharma's injectable drug Xyosted to treat low testosterone levels in men.
The decision comes almost a year after being rejected for elevated blood pressure, depression and suicidal tendencies in patients. But the approval means the drug will come the FDA’s strongest boxed warning that highlights the risks of a rise in blood pressure that can cause major cardiovascular events.
Xyosted’s approval makes it the second branded injectable testosterone replacement therapy in the low-T market. The drug has been approved in 50 mg, 75 mg and 100 mg dosages.
Read the Reuters report