FDA Approves First Generic Transdermal Patch for Menopausal Symptoms

The U.S. Food and Drug Administration (FDA) has approved the first generic version of Climara Pro, a once-weekly transdermal system combining estradiol and levonorgestrel. The patch is designed for postmenopausal women with an intact uterus to treat moderate to severe vasomotor symptoms (such as hot flashes) and prevent postmenopausal osteoporosis. This approval aligns with recent clinical guidance and endorsements from major medical organizations, including the American College of Obstetricians and Gynecologists (ACOG) and the American College of Physicians (ACP).

“Menopause is a universal experience for women, and it can greatly affect a person’s quality of life. This approval makes effective treatment more accessible,” said Acting FDA Commissioner Kyle Diamantas, J.D. “Approvals like this reflect FDA’s ongoing commitment to expanding American patient access to safe, affordable, high-quality medications.”

The generic estradiol and levonorgestrel transdermal system is therapeutically equivalent to Climara Pro, which is indicated for use in women with an intact uterus for:

• Treatment of moderate to severe vasomotor symptoms due to menopause

• Prevention of postmenopausal osteoporosis

Climara Pro and the generic estradiol and levonorgestrel transdermal system contain both estrogen and progestogen in a single patch; this differs from estrogen-only patches commonly used in menopause treatment. Climara Pro and the generic estradiol and levonorgestrel transdermal system are specifically approved for women with an intact uterus, as the progestogen component is included to reduce the risk of endometrial hyperplasia that can occur with estrogen use alone.

“Once-weekly dosing can make a real difference in how patients manage their care,” said Michael Davis, M.D., Ph.D., Director of FDA's Center for Drug Evaluation and Research . “A patch offers a convenient alternative to daily oral medications, which may help patients stay on track with their treatment.”

Climara Pro and the generic estradiol and levonorgestrel transdermal system are contraindicated in patients with undiagnosed abnormal genital bleeding; breast cancer or a history of breast cancer; estrogen-dependent neoplasia; active deep vein thrombosis (DVT), pulmonary embolism (PE) or a history of these conditions; active arterial thromboembolic disease or a history of these conditions; known anaphylactic reaction or angioedema or hypersensitivity to estradiol and levonorgestrel; hepatic impairment or disease; and protein C, protein S, or antithrombin deficiency, or other thrombophilic disorders.

The most common adverse reactions (greater than or equal to 5%) are: application site reaction, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, headache and flu syndrome.

In the U.S., nine out of 10 prescriptions filled are for generic drugs. Increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to healthcare for more patients. Learn more about the FDA Drug Competition Action Plan.

Climara Pro is a registered trademark of Bayer. The FDA approved Zydus Pharmaceuticals (USA) Inc.’s Estradiol and Levonorgestrel Transdermal System. Please contact the manufacturer for information about the medicine’s availability.