Mylan Launches Generic Version of Menopause Drug

Mylan Inc. has announced the US launch of its estradiol transdermal system, the generic version of Novartis' Vivelle-DOT.

The announcement follows the FDA’s final approval of Mylan’s Abbreviated New Drug Application for the product, which is indicated for the treatment of moderate-to-severe vasomotor symptoms and 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 US transdermal product launch and strengthens the company's growing portfolio of women's health products,” said Mylan CEO Heather Bresch in a press release. “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."

Mylan’s estradiol transdermal system will be available in twice-weekly strengths of 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day.