EMA accepts Pfizer's bazedoxifene/CE marketing application
The European Medicines Agency has accepted for review drug behemoth Pfizer’s (NYSE: PFE) Marketing Authorization Application for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for postmenopausal women with a uterus for the treatment of estrogen deficiency symptoms and treatment of osteoporosis in women at risk of fracture. Pfizer expects a decision from the European Commission in 2013.
Under the brand name Conbriza, bazedoxifene alone is marketed in Spain through a co-promotion with that country’s biggest drugmaker Almirall. It was approved in April 2009 by the European Commission for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. The combination drug is still under review in the USA, where the proposed trade name is Aprela.
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