Perrigo has received final approval from the Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Testosterone Topical Solution, the generic version of Eli Lilly‘s Axiron Topical Solution.
Axiron is indicated as testosterone replacement therapy in adult males who have low or no testosterone due to congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism. 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. Effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution.
Testosterone Topical Solution will be available as a 30mg/1.5mL strength solution.
For more information call (866) 634-9120 or visit Perrigo.com.