PITTSBURGH, Dec. 22, 2014 /PRNewswire/ -- Mylan Inc.
(Nasdaq: MYL) today 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 (Twice Weekly), which is the generic
version of Novartis' Vivelle-DOT®. Mylan received final
approval from the U.S. Food and Drug Administration (FDA) for its
Abbreviated New Drug Application (ANDA) 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.(1)
Mylan CEO Heather Bresch
commented: "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. 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 USP, 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 approximately $262.5 million
for the 12 months ending September 30,
2014, according to IMS Health.
Currently, Mylan has 285 ANDAs pending FDA approval representing
$111.3 billion in annual brand sales,
according to IMS Health. Forty-four of these pending ANDAs are
potential first-to-file opportunities, representing $29.3 billion in annual brand sales, for the 12
months ending June 30, 2014,
according to IMS Health.
Mylan is a global pharmaceutical company committed to setting
new standards in health care. Working together around the world to
provide 7 billion people access to high quality medicine, we
innovate to satisfy unmet needs; make reliability and service
excellence a habit; do what's right, not what's easy; and impact
the future through passionate global leadership. We offer a growing
portfolio of more than 1,300 generic pharmaceuticals and several
brand medications. In addition, we offer a wide range of
antiretroviral therapies, upon which approximately 40% of HIV/AIDS
patients in developing countries depend. We also operate one of the
largest active pharmaceutical ingredient manufacturers and
currently market products in approximately 140 countries and
territories. Our workforce of more than 25,000 people is dedicated
to improving the customer experience and increasing pharmaceutical
access to consumers around the world. Learn more at mylan.com.
This press release includes statements that constitute
"forward-looking statements," including with regard to the
company's strategy, future growth and performance. These statements
are made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Because such statements
inherently involve risks and uncertainties, actual future results
may differ materially from those expressed or implied by such
forward-looking statements. Factors that could cause or contribute
to such differences include, but are not limited to: the impacts of
competition; changes in economic and financial conditions of the
company's business; strategies by competitors or other third
parties to delay or prevent product introductions; risks inherent
in legal and regulatory processes; uncertainties and matters beyond
the control of management; and the other risks detailed in the
company's filings with the Securities and Exchange Commission. The
company undertakes no obligation to update these statements for
revisions or changes after the date of this release.
(1) There is an increased risk of endometrial cancer, stroke and
deep vein thrombosis in a woman who uses unopposed estrogens.
Estrogen-alone therapy should not be used for the prevention of
cardiovascular disease or dementia. The Women's Health
Initiative (WHI) reported an increased risk of developing dementia
in postmenopausal women 65 years of age or older, as well as, an
increased risk of invasive breast cancer and myocardial infarction
if taking Estrogen plus progestin.
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SOURCE Mylan Inc.