Abbott Receives FDA Approval for AndroGel 1.62%
AndroGel 1.62% showed it can restore and maintain testosterone levels in men for up to one year.
Abbott Laboratories announced that the US 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. The gel will be available in the second quarter of this year.
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-da
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