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Bazedoxifene is used in the prevention of postmenopausal osteoporosis. [5] Osteoporosis represents a major public health concern, especially as the number of postmenopausal women continues to rise. As a result, the need for innovative treatments has become increasingly important.
Lasofoxifene, sold under the brand name Fablyn, is a nonsteroidal selective estrogen receptor modulator (SERM) which is marketed by Pfizer in Lithuania and Portugal for the prevention and treatment of osteoporosis and for the treatment of vaginal atrophy, [1] [2] and the result of an exclusive research collaboration with Ligand Pharmaceuticals (LGND).
In May 2003, the US Food and Drug Administration (FDA) approved ibandronate as a daily treatment for post-menopausal osteoporosis. [medical citation needed] The basis for this approval was a three-year, randomized, double-blind, placebo-controlled trial women with post-menopausal osteoporosis.
The Bureau was transferred from the NIH to the FDA in 1972, where it was renamed Bureau of Biologics and focused on vaccines, serums for allergy shots, and blood products. [ 8 ] Ten years later, with the beginning of the biotechnology revolution , the line between a drug and a biologic, or a device and a biologic, became blurred. [ 8 ]
In June 2010, denosumab was approved by the FDA for use in postmenopausal women with risk of osteoporosis [31] under the brand name Prolia, [32] and in November 2010, as Xgeva for the prevention of skeleton-related events in people with bone metastases from solid tumors. [33] Denosumab is the first RANKL inhibitor to be approved by the FDA. [31]
The EC grants marketing authorization to Amgen (AMGN) and partner UCB's Evenity for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
This is a complete list of estrogens and formulations that are approved by the FDA Tooltip Food and Drug Administration and available in the United States. Estrogens are used as hormonal contraceptives, in hormone replacement therapy, and in the treatment of gynecological disorders.
Raloxifene, sold under the brand name Evista among others, is a medication used to prevent and treat osteoporosis in postmenopausal women and those on glucocorticoids. [6] For osteoporosis it is less preferred than bisphosphonates. [6] It is also used to reduce the risk of breast cancer in those at high risk. [6] It is taken by mouth. [6]