HERTFORDSHIRE, England and
PITTSBURGH, Dec. 1, 2017 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL), a global pharmaceutical company, today
announced it has received final approval from the U.S. Food and
Drug Administration (FDA) for its Abbreviated New Drug Applications
(ANDAs) for Heparin Sodium Injection USP, 1,000 USP/mL, 5,000
USP/mL, 10,000 USP/mL, and 20,000 USP/mL, all of which are packaged
in multi-dose vials.
Heparin is a complex injectable used as an anticoagulant in
blood transfusions, extracorporeal circulation and dialysis
procedures to prevent and treat various types of blood clots and to
treat atrial fibrillation with embolization.
Mylan's President Rajiv Malik
commented, "We are very proud of today's FDA approval of Heparin
Sodium Injection as this approval adds yet another highly complex
and difficult-to-manufacture product to our portfolio. Our
investments over the last decade in our scientific and
manufacturing capabilities, particularly in the injectables space,
continue to pay off as we create a leading portfolio and a robust
pipeline of complex products that differentiate us amongst our
peers.
"We look forward to adding this product as well as other future
product approvals to Mylan's already very robust injectable
portfolio, which is one of the largest in the industry, with
approximately 80 products available to patients in the U.S. across
a broad array of therapeutic categories. We expect to make our
Heparin products available to U.S. hospitals in the coming weeks,
further supporting our institutional customers in meeting the needs
of their patients who depend on high-quality anticoagulants."
U.S. sales for Heparin Sodium Injection USP, 1,000 USP/mL, 5,000
USP/mL, 10,000 USP/mL, and 20,000 USP/mL were approximately
$185 million for the 12 months ending
Oct. 31, 2017, according to
IQVIA.
Currently, Mylan has 211 ANDAs pending FDA approval,
representing approximately $93.2
billion in annual brand sales. Forty-five of these pending
ANDAs are potential first-to-file opportunities, representing
$42.1 billion in annual brand sales,
for the 12 months ending August 31,
2017, according to IQVIA. Currently, one out of every 13
prescriptions filled in the U.S. – brand-name or generic – is a
Mylan product.
This press release includes statements that constitute
"forward-looking statements," including with regard to
FDA approval of Heparin Sodium Injection demonstrating
Mylan's deep expertise in developing complex products; this
approval adding yet another highly complex and
difficult-to-manufacture product to our
portfolio; Mylan's investments over the last
decade in our scientific and manufacturing capabilities,
particularly in the injectables space, continuing to pay off as
Mylan creates a leading portfolio and a robust pipeline of complex
products that differentiates us amongst our peers;
looking forward to adding this product as well as other
future product approvals to Mylan's already very robust injectable
portfolio; and expecting to make our Heparin products available to
U.S. hospitals in the coming weeks, further supporting our
institutional customers in meeting the needs of their patients who
depend on high-quality anticoagulants. 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.
View original content with
multimedia:http://www.prnewswire.com/news-releases/fda-approval-of-heparin-sodium-injection-continues-to-demonstrate-mylans-deep-expertise-in-developing-complex-products-300565259.html
SOURCE Mylan N.V.