April 11, 2019
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FDA approves marketing of generic testosterone gel

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The FDA on Thursday approved marketing of a generic version of testosterone gel 1.62% as replacement therapy for men with hypogonadism, according to a press release from Lupin.

Testosterone gel 1.62% (20.25 mg/1.25 g pump actuation) is the generic equivalent of AbbVie’s AndroGel, 1.62%, first approved by the FDA in 2011. It is indicated for replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone, including congenital or acquired primary hypogonadism and congenital or acquired hypogonadotropic hypogonadism, according to the release.

The generic approval follows an agency approval in March for oral testosterone undecanoate, the first new oral testosterone replacement product in more than 60 years. Oral testosterone undecanoate (Jatenzo, Clarus Therapeutics) is indicated for men with low testosterone levels due to specific medical conditions, such as Klinefelter syndrome or tumors that have damaged the pituitary gland, and should not be used to treat men with so-called age-related hypogonadism, according to the FDA.