MYL Mylan launches generic version of Vivelle-DOT
Mylan announced the U.S. launch of its Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day, which is the generic version of Novartis' Vivelle-DOT. Mylan received final approval from the FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of moderate to severe vasomotor symptoms and moderate to severe symptoms of vulvar and vaginal atrophy due to menopause; hypoestrogenism due to hypogonadism, castration or primary ovarian failure; and the prevention of postmenopausal osteoporosis. Currently, Mylan has 285 ANDAs pending FDA approval representing $111.3B in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3B in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health. :theflyonthewall.com
