FDA approves Axiron

INDIANAPOLIS — Eli Lilly and Australian drug maker Acrux have received approval from the Food and Drug Administration for a testosterone replacement therapy for men, the two companies announced Tuesday.

The FDA approved Axiron (testosterone) topical solution as a treatment for men with various conditions that lead to deficiency of the hormone. The drug, a controlled substance, is designed for application under the arm.

It is estimated that up to 13 million men older than 45 years have symptoms associated with low testosterone, according to a study by the National Institutes of Health.