Perrigo Approved for Testosterone Gel 1%

Perrigo announced that it has received approval from the FDA for its New Drug Application (NDA) for Testosterone Gel 1%, the generic version of AbbVie’s AndroGel 1%.

AndroGel, a Schedule III controlled substance, is an androgen indicated for testosterone replacement therapy in adult males. Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics.

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