August 13, 2010 – HRA Pharma announced that the US Food and Drug Administration (FDA) granted approval for ella® (ulipristal acetate) as a prescription-only emergency contraceptive indicated for use within 120 hours (five days) of unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine use as a contraceptive.The approval is based on two Phase 3 studies that showed that ella significantly reduced the risk of pregnancy in women who used it after unprotected intercourse. A progesterone agonist/antagonist that potently inhibits follicular rupture when taken just before ovulation is to occur, ella has been shown to be consistently effective when used up to five days after intercourse. Currently-marketed emergency contraceptives based on levonorgestrel are labeled for use within 72 hours or three days of intercourse.
“As a pioneer and a leader in the field of emergency contraception, HRA Pharma is committed to providing women and their health care providers highly effective contraceptive options...
[...]
...The product will be launched and marketed in the US by HRA Pharma’s partner Watson Pharmaceuticals, Inc. The two companies announced their license agreement earlier this year...
[...]
...About HRA Pharma
HRA Pharma is a privately-held European pharmaceutical company that designs products, devices and supporting services in niche areas of health and makes them available to doctors and patients worldwide. The company targets therapeutic gaps in the areas of reproductive health and endocrinology, and uses innovative marketing solutions and socially-conscious programs, such as contraception education in developing countries, to promote healthy management of drugs and diseases. A pioneer in emergency contraception, its product ulipristal acetate can be taken for up to five days after unprotected sexual intercourse and is the only product licensed in the European Union (ellaOne®) and the U.S. (ella®) for this indication. Headquartered in Paris, France...[PDF] HRA Pharma's Press Release -
[...]
...About HRA Pharma
HRA Pharma is a privately-held European pharmaceutical company that designs products, devices and supporting services in niche areas of health and makes them available to doctors and patients worldwide. The company targets therapeutic gaps in the areas of reproductive health and endocrinology, and uses innovative marketing solutions and socially-conscious programs, such as contraception education in developing countries, to promote healthy management of drugs and diseases. A pioneer in emergency contraception, its product ulipristal acetate can be taken for up to five days after unprotected sexual intercourse and is the only product licensed in the European Union (ellaOne®) and the U.S. (ella®) for this indication. Headquartered in Paris, France...[PDF] HRA Pharma's Press Release -
