FDA Takes Step Forward on Testosterone Therapy for Men

WHY IT MATTERS

Men with idiopathic hypogonadism who experience low libido may soon have an FDA-approved treatment option specifically designed for this symptom, rather than relying on off-label use of existing testosterone therapies.

The FDA is inviting companies that make testosterone replacement therapy drugs to apply for approval of a new use: treating low sex drive in men with a specific condition called idiopathic hypogonadism (when the body doesn't make enough testosterone for unknown reasons). This is an early step that could lead to new treatment options for men with this condition.

FDA is taking an initial step to advance treatment options for men’s health by encouraging sponsors of approved testosterone replacement therapy products to contact FDA for information if they are interested in pursuing a potential new indication for low libido in men with idiopathic hypogonadism.