The FDA has granted marketing approval for a new generic estradiol/levonor-gestrel transdermal (skin patch) system (Climara Pro®) for the treatment of menopausal symptoms. This thin, translucent patch is the first once-weekly combined hormone therapy approved in the U.S. Schering’s U.S. subsidiary, Berlex, Inc., plans to launch Climara Pro® in January 2004.
The transdermal (patch) technology allows for a continuous delivery of hormones at doses much lower than those in pills. Easily affixed to the skin, Climara Pro® delivers 0.015 mg/day of levo-norgestrel and 0.045 mg/day of estra-diol. Estradiol canadian is the most active estrogen made by the ovary. This therapy is approved for the relief of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.
Climara®, Schering’s once-weekly estrogen-only patch, is appropriate for women who have had a hysterectomy. With the addition of drug levonorgestrel, Climara Pro® is indicated for women with an intact uterus.