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Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the Orange Book contains therapeutic equivalence evaluations (2 character rating codes) for approved multisource prescription drug products (generic drugs).
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
Romosozumab is used for osteoporosis to decrease the risk of fractures. [10] Two trials found that it reduced the rate of vertebral fracture. In one, there was a 73% lower risk of vertebral fracture after one year, and the benefit was maintained after a second year of taking denosumab.
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]
Osteoporosis drugs taken to prevent bone fracture may cause rare, but critical, fractures of their own, the Food and Drug Administration announced today in a warning to consumers. The agency also ...
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.
Vaccine Excipients Adenovirus vaccine: This list refers to the type 4 and type 7 adenovirus vaccine tablets licensed in the US: Acetone, alcohol, anhydrous lactose, castor oil, cellulose acetate phthalate, dextrose, D-fructose, D-mannose, FD&C Yellow #6 aluminium lake dye, fetal bovine serum, human serum albumin, magnesium stearate, micro crystalline cellulose, plasdone C, Polacrilin potassium ...
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.