Overview
- The move covers more than 20 estrogen- and progestin-containing pills, patches and creams, with manufacturers asked to update labels in the coming months.
- A boxed warning will remain for endometrial cancer risk on systemic estrogen‑only products for women with a uterus, and labels will add guidance to start therapy before age 60 or within 10 years of menopause.
- Regulators say newer analyses show lower risks for appropriately timed use, refining conclusions from the 2002 Women’s Health Initiative trial that involved older participants.
- Supporters expect increased access and prescribing after a two‑decade decline, while critics question the review process and note the FDA did not convene a formal independent advisory committee.
- The FDA also approved a generic version of Premarin and a non‑hormonal treatment for hot flashes as part of Monday’s actions.