FDA Works With Six Makers to Ease Estrogen Patch Shortages

The U.S. Food and Drug Administration (FDA) said on Thursday it is coordinating with all six manufacturers of estradiol transdermal patches to increase supply. The move follows reports that patients are struggling to find the products, which deliver estrogen to ease menopause symptoms like hot flashes, mood swings, and sleep issues.

A surge in demand has strained inventories, even though the regulator has not formally listed the patches as being in shortage. Women have reported visiting multiple pharmacies, changing dosages, or switching brands and therapy types to secure their medication.

The FDA noted that availability varies by pharmacy and location, but the patches remain on the market. It did not name the companies involved. However, industry data from the American Society of Health-System Pharmacists indicates shortages among major producers such as Sandoz, Viatris, Noven, and Zydus. Other firms in the space include Amneal and Viatris.

Manufacturers are responding by adding shifts, expanding capacity, increasing batch sizes, and installing specialized equipment and production lines. The FDA is monitoring supply and has offered to expedite reviews of submissions tied to boosting output.

The demand spike follows the FDA's earlier decision to remove a long-standing "boxed warning" on these products, which had highlighted risks such as cardiovascular disease, breast cancer, and probable dementia. With more than one million U.S. women entering menopause each year, the agency is acting to ensure consistent access to this therapy.