Content about Menopause

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for postmenopausal women who experience pain during sex.

The agency announced the approval of Shionogi's Osphena (ospemifene) for women with moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause associated with declining levels of estrogen hormones.

NEW YORK — The Electronic Retailing Self-Regulation Program on Tuesday recommended that Casper Labs modify or discontinue certain claims for Calmestra, a dietary supplement marketed as providing relief for symptoms of menopause, including claims that the product has been “clinically proven” to address symptoms of menopause.

THOUSAND OAKS, Calif. — The Food and Drug Administration has approved a new usage for an Amgen drug, the drug maker said.

The biotech manufacturer announced the FDA approval of Prolia (denosumab) to increase bone mass in men with osteoporosis who are at high risk for fracture. The drug already was approved for osteoporosis in postmenopausal women.

FLORHAM PARK, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug made by Shionogi for treating vulvar and vaginal atrophy due to menopause.

Shionogi, the U.S. division of Japanese drug maker Shionogi & Co., said Wednesday that the FDA had accepted for review its application for ospemifene, which the company touts as potentially the first oral alternative to vaginal estrogen treatments.

SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic version of a drug for treating and preventing osteoporosis in women after menopause, the agency said Monday.

The FDA announced the approval of ibandronate tablets in the 150-mg strength made by Apotex, Orchid Healthcare and Mylan Pharmaceuticals. Genentech makes the branded version of the drug.

PARSIPPANY, N.J. — Watson has launched an authorized generic drug for treating postmenopausal women, the company said Friday.

Watson announced the launch of progesterone capsules in the 100-mg and 200-mg strengths, an authorized generic version of Abbott Labs' Prometrium, under an agreement with Abbott. Abbott will manufacture the drug and supply it to Watson, which will market and distribute it and share profits. Other terms were not disclosed, the companies said.

THOUSAND OAKS, Calif. — Amgen has launched an educational campaign that targets women with postmenopausal osteoporosis at increased risk for fractures.

The drug maker said that to promote its Act 2 Reduce Fractures campaign, which is supported by American Bone Health, the Global Healthy Living Foundation and the Older Women's League, the company has tapped award-winning actress Blythe Danner, who was diagnosed with the disease, to encourage women to learn of the risk factors and ways to improve their condition.

WASHINGTON — A major depressive disorder treatment made by Pfizer significantly reduced the number and severity of moderate-to-severe hot flashes in postmenopausal women, compared with placebo, according to a new study.

CHICAGO — Smoking before menopause, especially prior to giving birth, may be associated with a modest increase in the risk of developing breast cancer, according to a report in the Jan. 24 issue of Archives of Internal Medicine.

WASHINGTON The Food and Drug Administration has approved a new treatment for gout, a painful condition that affects 3 million adults in the United States.

The FDA announced the approval of Savient Pharmaceuticals’ Krystexxa (pegloticase), a biotech drug for people who have not responded to or tolerated conventional therapies.