AndroGel FDA Approval History: Complete Regulatory Timeline

The timeline, in the order FDA published it

• January 2014. A Drug Safety Communication warned of reported risks of stroke, heart attack and death in men taking testosterone products. A joint advisory committee meeting in September 2014 led FDA to recommend an industry-wide trial to assess safety in men with age-related hypogonadism [1].
• March 2015. A second Drug Safety Communication informed of required labeling changes and urged caution when testosterone products are used for low testosterone due to aging [1].
• 2016 to 2018. FDA recommended ambulatory blood pressure monitoring studies during premarket development of two testosterone products. In March 2018 it required individual studies for all testosterone products [1].
• June 2023. TRAVERSE results were published [2].
• February 28, 2025. FDA announced class-wide labeling changes [1].
• June 2026. FDA requested a further round of label updates [2].

What the February 28, 2025 action changed

After reviewing TRAVERSE and the completed ambulatory blood pressure studies, FDA listed five changes. Based on TRAVERSE, it recommended adding the trial results to all testosterone labels, retaining the Limitation of Use for age-related hypogonadism, and removing boxed-warning language about an increased risk of adverse cardiovascular outcomes. Based on the blood pressure studies, it required adding product-specific blood pressure information where monitoring studies were completed, and a new blood pressure warning for products that had none [1]. FDA stated that the completed monitoring studies confirmed an increase in blood pressure with all testosterone products, class-wide [1].

TRAVERSE, the trial behind the change

FDA describes TRAVERSE as an FDA-required postmarketing safety trial run by an industry consortium led by manufacturers of AndroGel and Androderm. It tracked cardiovascular death, nonfatal heart attack and nonfatal stroke in men given AndroGel 1.62% or placebo [2]. The trial randomized 5246 men aged 45 to 80 with hypogonadism and preexisting or high risk of cardiovascular disease to daily testosterone gel or placebo gel [3]. Results published in June 2023 showed a major adverse cardiovascular event in 7.0% of men on AndroGel versus 7.3% on placebo. FDA concluded that the trial did not demonstrate a new safety signal or trend in adverse cardiovascular outcomes with testosterone use [2].

June 2026 and the current position

FDA's testosterone page, current as of June 23, 2026, says that after a review including TRAVERSE and a reanalysis of existing evidence, FDA requested two updates to prescribing information. One removes the limitation of use stating that safety and efficacy in men with age-related hypogonadism have not been established. The other revises safety information on prostate cancer and benign prostatic hyperplasia [2]. These are requested changes. Testosterone injection labels checked after that request still carried the old limitation text. FDA also states that none of the approved testosterone products is approved for low testosterone in men who lack an associated medical condition [2].