PITTSBURGH — Mylan Inc. has launched its 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), a patch medication for menopause symptoms, in the U.S. market.
The company said Monday that its Estradiol Transdermal System product is the generic version of Novartis’ Vivelle-DOT.
Mylan received final approval from the Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product, 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 launch and strengthens the company’s growing portfolio of women’s health products," Mylan chief executive officer Heather Bresch commented. "We look forward to continuing to meet patient needs in this space as we strive to provide the world’s 7 billion people access to high quality medicines."
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) had U.S. sales of about $262.5 million for the 12 months ended Sept. 30, according to IMS Health data reported by Mylan.
