Mylan Launches First Generic Version of Novartis’s Vivelle-DOT

Mylan Inc. Dec. 22 announced that it has launched the first generic version of Novartis Pharmaceutical Inc.'s Vivelle-DOT (estradiol transdermal system) 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day (twice weekly).

Mylan said the Food and Drug Administration approved its abbreviated new drug application for this product.

Vivelle-DOT 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.

“The approval of Mylan’s Estradiol Transdermal System USP represents our seventh U.S. transdermal product ...