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news.Vivelle Ventures, Noven Pharmaceuticals and Novartis Pharmaceuticals have filed a lawsuit against Mylan regarding the US Food and Drug Administration (FDA) filing of an abbreviated new drug application (ANDA) of Estradiol Transdermal System, USP (Twice-Weekly), 0.025mg/day, 0.0375mg/day, 0.05mg/day, 0.075mg/day and 0.1mg/day.
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The companies filed the lawsuit in the US District Court for the Southern District of New York and the US District Court for the District of Vermont.
Reportedly, Estradiol Transdermal System, USP is the generic version of Vivelle-Dot, which is used to treat symptoms associated with menopause and hypoestrogenism and also prevents postmenopausal osteoporosis.