FDA Approves Once-Weekly Generic Hormone Therapy Patch For Women

First Generic Weekly Estrogen-Progestin Patch Wins FDA Approval as Women Still Struggle to Fill Menopause Prescriptions

FDA approved the first generic Climara Pro, a weekly estrogen-progestin patch, as women report trouble filling patches. What it changes for access.

The FDA Just Approved a New Hormone Therapy Patch. Will It Ease the Shortage?

The FDA approved a generic version of Climara Pro. Here’s who it’s for, what it could mean for costs, and whether it may ease patch shortages.

First generic combo hormone patch could make menopause relief more affordable

Women looking for relief from menopause symptoms could soon have a more affordable option for a weekly hormone patch.

FDA Approves Once-Weekly Generic Hormone Therapy Patch For Women

The U.S. Food and Drug Administration has approved the first generic of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg per day/0.015 mg), a transdermal hormone therapy patch for women with an intact uterus applied once a week. The approval aligns with FDA's Public Health Pillar: Increasing Access to Affordable Medicines & Medical Products.

Zydus’ generic of hormone therapy patch gets U.S. FDA nod

The product is eligible for the 180-day exclusivity period available to certain first approved applicants under the CGT pathway, subject to the provisions of the U.S. Federal Food, Drug, and Cosmetic Act.

Zydus Lifesciences gets USFDA nod for menopause treatment drug

The final approval granted by the US Food and Drug Administration (USFDA) is for Estradiol and Levonorgestrel Transdermal System (0.045 mg/0.015 mg per day)