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ARTICLE | Company News

FDA approves Shionogi's ospemifene

February 27, 2013 1:44 AM UTC

FDA approved an NDA from Shionogi & Co. Ltd. (Tokyo:4507; Osaka:4507) for Osphena ospemifene to treat moderate to severe dyspareunia due to postmenopausal vulvovaginal atrophy. The drug's label includes a boxed warning that it can cause endometrial thickening and an increased risk of stroke and deep vein thrombosis (DVT). The warning includes the incidence rates with Osphena for thrombotic and hemorrhagic strokes and DVT, but according to the agency the rates "represent low risks in contrast to the increased risks" with estrogen-alone therapy. ...