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ABBOTT PARK, Ill. — Abbott has received approval from the Food and Drug Administration for its new AndroGel 1.62% testosterone gel.
The company said Friday that AndroGel 1.62%, a clear, odorless gel formulation, was shown to restore testosterone levels in hypogonadal men with half the volume of gel at the starting dose compared with AndroGel 1%.
Plans call for AndroGel 1.62% to become available to patients during the second quarter.
At the starting dose, the new AndroGel 1.62% contains 40.5 mg of testosterone in two pump presses, whereas AndroGel 1% contains 50 mg of testosterone in four pump presses, according to Abbott. The company noted that dosage and administration for AndroGel 1.62% differs from AndroGel 1%, and the two treatments aren’t interchangeable.
Both AndroGel 1.62% and AndroGel 1% are prescription medications used to treat adult males with low testosterone or no testosterone, also known as hypogonadism.
"Low testosterone is a real concern for many men, and it is important that men exhibiting signs and symptoms talk to their doctor about appropriate testing and treatment," Natan Bar-Chama, M.D., director of male reproductive medicine and surgery at The Mount Sinai Hospital in New York, said in a statement released by Abbott. "AndroGel 1.62% is an important new option that was shown in a clinical trial to restore and maintain testosterone levels in men for up to one year."
Nearly 14 million men in the United States may have low testosterone levels, Abbott reported. "AndroGel 1% has been trusted by patients and physicians for more than a decade," commented Jim Hynd, divisional vice president of metabolics for Abbott. "With the approval of AndroGel 1.62%, Abbott now offers another innovation in testosterone delivery for men with hypogonadism to treat their condition."
