Lilly, Acrux Gain Approval for Testosterone Therapy

Eli Lilly and Co. and Acrux received approval from the FDA for Axiron (testosterone) topical solution CIII for replacement therapy in men for conditions associated with a deficiency or absence of testosterone. Study results show that Axiron can restore blood concentration of testosterone within the normal range in most men.

Axiron is the first testosterone topical solution approved for application via an underarm applicator. Other forms include: oral tablets, subcutaneous, transdermal patches, injections, and hand applied topical gels.

“Lilly is proud to expand our focus in men’s health,” said David Ricks, president, Lilly USA. “The addition of Axiron to our product portfolio reinforces Lilly’s commitment to provide innovative treatment options for patients.”

“The FDA approval is a major milestone for Axiron and for Acrux,” said Dr. Richard Treagus, chief executive officer, Acrux. “After years of research, we are excited to partner with Lilly to provide this novel application method for men with low testosterone.”