Tibolone is a synthetic steroid hormone that has estrogen, androgen, and progestogen properties. It restores the imbalanced female hormones during menopause and manages night sweats and hot flashes. Also, this is prescribed to women who missed their periods for a year to prevent osteoporosis. Tibolone is produced by Organon Pharmaceuticals in West Orange, New Jersey. It comes in tablets and has been used in Europe for 2 decades as treatment and prevention of postmenopausal osteoporosis and postmenopausal symptoms. Additionally, it is approved in 90 countries to manage menopause symptoms and in 45 countries to prevent osteoporosis development. Regulation The FDA didn’t approve tibolone for use in the United States (Organon Pharmaceuticals received a ‘Not Approvable’ letter from the FDA). The treatment’s increased breast cancer and stroke risks, and its androgenic effects (it can act like male hormones in the body) are the factors contributed to FDAs decision. Tibolone is approved ...