FDA Approves ‘Designer Estrogen’

The Food and Drug Administration approved a new osteoporosis drug Wednesday that some doctors say offers the benefits of estrogen without many of the drawbacks.

It does not protect bone quite as well as estrogen, but the FDA said raloxifene, the first so-called designer estrogen, works well enough to offer it to the estimated 10 million post-menopausal women at risk for the bone-thinning disease.

It is an option for women who are worried that long-term estrogen use can increase the risk of breast cancer, or who don’t like the fact that the hormone can restart their menstrual periods, said Dr. Solomon Sobel, FDA’s chief of endocrinologic drugs.

Eli Lilly & Co. will sell raloxifene under the brand name Evista. It will be on pharmacy shelves by early January.

The FDA also approved a new nose-spray formulation of Novartis Pharmaceuticals’ Migranal migraine medication, the company said Wednesday.

Also, an FDA advisory panel urged approval of Biex Inc.’s SalEst, a saliva test that may help identify women about to enter premature labor.