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Abbott AndroGel 1.62% gets FDA approval

Abbott has received the US Food and Drug Administration's (FDA) approval for AndroGel (testosterone gel) 1.62%, a low-volume formulation to help restore low testosterone levels in men.

AndroGel (testosterone gel) 1.62% is a clear, odorless, gel formulation shown to restore testosterone levels in hypogonadal men with half the volume of gel at the starting dose compared to AndroGel 1%.

At the starting dose, the new AndroGel 1.62% contains 40.5mg of testosterone in two pump presses, whereas AndroGel 1% contains 50mg of testosterone in four pump presses.

The company expects to launch AndroGel 1.62% in the second quarter of 2011.

Abbott Metabolics divisional vice president Jim Hynd said AndroGel 1% has been trusted by patients and physicians for more than a decade.

"With the approval of AndroGel 1.62%, Abbott now offers another innovation in testosterone delivery for men with hypogonadism to treat their condition," Hynd said.