FDA Approves Once-Weekly Generic Hormone Patch for Women

The FDA approved the first generic version of Climara Pro yesterday. The estradiol and levonorgestrel transdermal system delivers 0.045 mg per day of estradiol and 0.015 mg per day of levonorgestrel through a once-weekly patch.

The generic was approved for women with an intact uterus. It is indicated for treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis. Zydus Pharmaceuticals (USA) Inc. received approval to manufacture the generic.

Acting FDA Commissioner Kyle Diamantas said the approval makes effective treatment more accessible for patients. Michael Davis, Director of FDA's Center for Drug Evaluation and Research, said once-weekly dosing can make a real difference in how patients manage their care. He said a patch offers a convenient alternative to daily oral medications.

The patch contains both estrogen and progestogen in a single application. This differs from estrogen-only patches commonly used in menopause treatment. The progestogen component reduces the risk of endometrial hyperplasia that can occur with estrogen use alone.

The FDA said the approval helps increase access to affordable medicines. The agency said nine out of 10 prescriptions filled in the U.S. are for generic drugs. Increasing the availability of generic drugs helps create competition and makes treatment more affordable. Climara Pro is a registered trademark of Bayer.

The most common adverse reactions include application site reaction, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, headache and flu syndrome. The generic is contraindicated in patients with various conditions including undiagnosed abnormal genital bleeding, breast cancer or history of breast cancer, active blood clots and certain other medical conditions.