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Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved AndroGel® (testosterone gel) 1.62%, 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 40.5 mg of testosterone in two pump presses, whereas AndroGel 1% contains 50 mg of testosterone in four pump presses. Dosage and administration for AndroGel 1.62% differs from AndroGel 1% and the two are not interchangeable. Both AndroGel 1.62% and AndroGel 1% are prescription medications used to treat adult males with low 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," said Natan Bar-Chama, M.D., director of Male Reproductive Medicine and Surgery, The Mount Sinai Hospital in New York. "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. The Endocrine Society developed guidelines for the diagnosis and treatment of hypogonadism, which note the normal range for testosterone as 300-1,000 ng/dL.

“AndroGel 1% has been trusted by patients and physicians for more than a decade,” said Jim Hynd, divisional vice president, Metabolics, Abbott. “With the approval of AndroGel 1.62%, Abbott now offers another innovation in testosterone delivery for men with hypogonadism to treat their condition.”

AndroGel 1.62% is expected to be available to patients in the second quarter of 2011.

[Press Release]