Drugs

FDA Helping to Increase Supply of Estradiol Patches

FDA says it is working with manufacturers to increase supplies of estradiol transdermal patches after reports that some patients are having difficulty finding their usual products at pharmacies.

In a 9/3 update, the agency says it is working with all six manufacturers of FDA-approved estradiol transdermal patches to increase supply. While availability of individual products and brands may vary depending on the pharmacy and location, the agency said estradiol patches remain available.

The supply difficulties are related to increased demand for menopausal hormone therapy, with more women seeking treatment for symptoms associated with menopause, including hot flashes and night sweats.

The agency said demand increased following its 11/2025 action requesting that manufacturers revise labeling for menopausal hormone therapy products to remove Boxed Warnings concerning a probable risk of breast cancer, cardiovascular disease and probable dementia in patients receiving hormone therapy for menopause.

According to FDA, the labeling changes were intended to provide women and their health care providers with updated information to support discussions about the potential benefits and risks of menopausal hormone therapy.

As it continuously monitors the potential shortage issue, FDA says that it can expedite reviews of submissions related to efforts to increase supply, where appropriate. Manufacturers have been taking additional steps to put more patches on the market, including increasing production, adding manufacturing shifts, expanding production capacity, increasing batch sizes, installing specialized equipment and manufacturing lines, and prioritizing estradiol patch production.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome