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News
The FDA is calling on manufacturers to conduct studies that could support approval of female-specific testosterone products, as off-label use among menopausal women has nearly tripled since 2020. No testosterone therapy is currently FDA-approved for women, despite evidence supporting its use for low sexual desire (HSDD). Experts warn that long-term safety data — especially around cardiovascular and breast cancer risks — remain limited.
The FDA held a public workshop this week urging drugmakers to generate data that could support future approvals of testosterone therapies specifically for women. Right now, no such product is FDA-approved in the US — even as the UK, Australia, New Zealand, and South Africa have already licensed female-specific formulations. Women and their doctors are left improvising, typically splitting doses from male-approved products like AbbVie's AndroGel or turning to pricier compounded formulations, with most insurers refusing to cover the cost.
The demand is real and growing. Testosterone prescriptions for women jumped roughly 249% between January 2020 and July 2026, driven partly by social media buzz around benefits like improved energy, muscle mass, and cognition. But experts caution that the evidence only firmly supports testosterone for hypoactive sexual desire disorder (HSDD) in postmenopausal women — not the broader wellness claims circulating online. Long-term safety data, particularly around cardiovascular and breast cancer risks, remain a significant gap.
By the Numbers
Why it matters: With prescriptions surging and pharmacies increasingly pushing back on off-label dispensing, the pressure on the FDA to act is mounting. A female-specific approved product could standardize dosing, improve insurance coverage, and give clinicians clearer safety guidance — but only if the evidence catches up.
