HERTFORDSHIRE, England and
PITTSBURGH, Dec. 29, 2017 /PRNewswire/ -- Global
pharmaceutical leader Mylan N.V. (NASDAQ, TASE: MYL) today
announced the U.S. launch of Estradiol Vaginal Cream USP, 0.01%,
the first generic version of Allergan's Estrace® Cream. 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 in the treatment of vulvar and vaginal
atrophy.
Mylan CEO Heather Bresch said,
"The approval and launch of Estradiol Vaginal Cream strengthens our
robust women's healthcare portfolio and our commitment to helping
women manage their health across every stage of their lives, from
contraception and hormone replacement therapy to certain disorders
that are highly prevalent in women, like hypothyroidism. Mylan is
now one of only a few companies that will offer Estradiol as an
option across four delivery systems – cream, gel, transdermal patch
and tablet. This breadth allows us to deliver multiple options and,
ultimately, greater value to customers, healthcare professionals
and patients. Further, introducing a first-time generic
demonstrates our leadership in continuing to create access to high
quality medicine for patients and the U.S. healthcare system."
Mylan President Rajiv Malik added, "Topicals like Estradiol
Vaginal Cream are a great example of Mylan's ability to bring to
market complex products. We have made substantial investments in
research and development of these difficult-to-develop medicines
and believe this provides long-term sustainability for our
business."
Estrogens increase the risk of endometrial cancer, and should
not be used for the prevention of cardiovascular disease or
dementia. Estrogen use is associated with an increased risk of
stroke, DVT and dementia in postmenopausal women. Because of the
risks associated with estrogen use, they should be prescribed at
the lowest effective dose and for the shortest duration.
Estradiol Vaginal Cream USP, 0.01%, had U.S. sales of
approximately $449 million for the 12
months ending Oct. 31, 2017,
according to IQVIA.
Currently, Mylan has 211 ANDAs pending FDA approval representing
approximately $93.4 billion in annual
brand sales, according to IQVIA. Forty-six of these pending ANDAs
are potential first-to-file opportunities, representing
$42.1 billion in annual brand sales,
for the 12 months ending July 31,
2017, according to IQVIA.
This press release includes statements that constitute
"forward-looking statements," including with regard to: the
approval and launch of Estradiol Vaginal Cream strengthening
Mylan's robust women's healthcare portfolio and our commitment to
helping women manage their health across every stage of their
lives; Mylan now being one of only a few companies that will
offer Estradiol as an option across four delivery systems – cream,
gel, transdermal patch and tablet; topicals like Estradiol Vaginal
Cream being a great example of Mylan's ability to not only produce
complex products, but to bring them to market first; this breadth
allowing Mylan to deliver multiple options and, ultimately, greater
value to customers, healthcare professionals and patients;
introducing a first-time generic demonstrating Mylan's leadership
in continuing to create access to high quality medicine for
patients and the U.S. healthcare system; and Mylan making
substantial investments in research and development of these
difficult-to-develop medicines and believing this provides
long-term sustainability for our business. 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: any changes in or difficulties with Mylan's or its
partners' ability to develop, manufacture, and commercialize
products; any regulatory, legal, or other impediments to Mylan's or
its partners' ability to bring products to market; Mylan's and its
partners' ability to protect intellectual property and preserve
intellectual property rights; the effect of any changes in Mylan's
or its partners' customer and supplier relationships and customer
purchasing patterns; other changes in third-party relationships;
the impact of competition; changes in the economic and financial
conditions of the businesses of Mylan or its partners; the scope,
timing, and outcome of any ongoing legal proceedings and the impact
of any such proceedings on Mylan's or its partners' business;
actions and decisions of healthcare and pharmaceutical regulators,
and changes in healthcare and pharmaceutical laws and regulations,
in the United States and abroad; risks associated with
international operations; other uncertainties and matters beyond
the control of management; and the other risks detailed in Mylan's
filings with the Securities and Exchange Commission. Mylan
undertakes no obligation to update these statements for revisions
or changes after the date of this release.
About Mylan
Mylan is a global pharmaceutical company
committed to setting new standards in healthcare. 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 7,500 marketed products around the
world, including antiretroviral therapies on which more than 40% of
people being treated for HIV/AIDS globally depend. We market our
products in more than 165 countries and territories. We are one of
the world's largest producers of active pharmaceutical ingredients.
Every member of our more than 35,000-strong workforce is dedicated
to creating better health for a better world, one person at a time.
Learn more at Mylan.com. We routinely post information that may be
important to investors on our website at investor.mylan.com.
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SOURCE Mylan N.V.