Schering AG has received an approval from the US Food and Drug Administration for its hormone therapy patch, Climara Pro (estradiol/levonorgestrel transdermal system), for the prevention of postmenopausal osteoporosis.
Climara Pro was approved by the FDA in November 2003 as a treatment for moderate to severe vasomotor symptoms such as hot flashes and night sweats associated with menopause. Climara Pro is the only combination once-a-week patch approved for the prevention of postmenopausal osteoporosis and the relief of moderate to severe vasomotor symptoms associated with menopause, states a Schering release.
"Climara Pro offers an innovative treatment option for menopausal symptoms and helps to maintain women's health. The approval for osteoporosis prevention supports our position in the field of menopause management. Schering is committed to providing the best care in this field," said Philip Smits, head of gynaecology and andrology at Schering AG.
The transdermal technology of Climara Pro allows for week-long continuous delivery of the hormone estradiol, the same estrogen made by the ovaries prior to menopause, combined with levonorgestrel, which helps protect the endometrium. Climara Pro delivers the hormones through a thin, translucent patch that is easily affixed to the skin and is virtually invisible after being applied.