US FDA has approved Berlex Inc's. (US affiliate of Schering AG, Germany) Angeliq (drospirenone and estradiol) to treat moderate to severe vasomotor symptoms associated with menopause. Angeliq will be the only hormone therapy to contain the unique progestin, drospirenone, claims the company release.

The estrogen component in Angeliq is estradiol, the same estrogen produced by the ovaries prior to menopause. The progestin drospirenone is a spironolactone analog with anti-aldosterone activity, a property that can cause the excretion of excess sodium and water while retaining potassium levels.

"Angeliq provides menopausal women and healthcare professionals with a new treatment option containing the progestin, drospirenone, which is also found in Yasmin, the number-one brand of oral contraceptive in the US and worldwide," said Reinhard Franzen, President and CEO of Berlex Laboratories.

The largest growing groups of women over age 50 are those between 50 and 54, which is typically when women experience the symptoms of menopause and seek ways to treat them.

According to the company release, Angeliq will be available in the US by prescription in mid-2006, in a preparation containing 0.5 mg drospirenone and 1 mg estradiol.

Angeliq has been on the market in Germany and some other European countries for about a year. The US approval comes one year after the US Food and Drug Administration told Schering it needed more manufacturing data before it could approve the drug, after first declining approval altogether.