In January 2010, Acrux submitted Axiron® (Testosterone Topical Solution, 30 mg / 1.5 mL) to the FDA. The product was approved in November 2010. Acrux and Eli Lilly entered into an exclusive worldwide licensing agreement for Axiron® in March 2010. Axiron® was marketed in the United States, Europe and a number of other countries.
About the testosterone product
Axiron® was the first testosterone topical solution approved for application via an armpit (underarm) applicator. Testosterone solution is used to treat adult males who have low or no testosterone. Other forms of testosterone replacement therapy include: oral tablets, buccal tablets, subcutaneous pellets, transdermal patches, injections and topical gels applied by the hands. Testosterone Topical Solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone such as Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired).
The launch of the generic versions of Axiron® made it no longer commercially viable to market Axiron® , and the product was withdrawn from the market in all countries in 2017.