Abbott Laboratories announced that the US Food and Drug Administration (FDA) has approved AndroGel (testosterone gel) 1.62%, a clear and odourless gel formulation shown to treat adult males with low or no testosterone, known as hypogonadism.
Normal range for testosterone ranges from 300-1,000ng/dL, with nearly 14 million men in the US reported to have low testosterone levels.
Signs and symptoms associated with male hypogonadism include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, depressed mood, osteoporosis and a diminishment in the physical characteristics of a man, such as decreased body hair.
The FDA approval of AndroGel 1.62% is based on a two-phase, 364-day controlled clinical study.
The study reported that 82% of hypogonadal men who took AndroGel 1.62% achieved a normal average testosterone level at day 112.
Mount Sinai Hospital male reproductive medicine and surgery director Natan Bar-Chama said that AndroGel 1.62% showed it can restore and maintain testosterone levels in men for up to one year.
The common side effects reported with the use of AndroGel 1.62% include increased prostate specific antigen and red blood cell count, mood swings, high blood pressure and skin irritation.
The gel will be available in the second quarter of this year.