What happened
On Sept 17, FDA’s Office of Women’s Health and Center for Drug Evaluation and Research (CDER) held a public workshop on testosterone use in menopausal women: benefits, dosing, lab interpretation and long-term safety, with the stated aim of informing research and drug development. There is still no FDA-approved testosterone indication or formulation for menopausal women, so prescribing runs on off-label male products or compounding. The evidence is strongest for hypoactive sexual desire disorder (HSDD); energy, mood and cognition are what patients ask about, without a guideline-backed indication behind them. Long-term cardiovascular and breast cancer data remain the regulatory bottleneck.
What it means for practice
This is the first time FDA has put the question on its own agenda, and a female-dose NDA path is now imaginable. For practices already prescribing off-label, the documented indication (usually HSDD), consent, assay choice and monitoring are what will read well if the regulatory picture sharpens.
Originally published in The Longevity Medicine Intelligence newsletter (#107).
