HERTFORDSHIRE, England and
PITTSBURGH, May 5, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced the U.S. launch of Hydralazine
Hydrochloride Injection USP, 20 mg/mL, which is a generic version
of Novartis' Apresoline Injection, 20 mg/mL. 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
used for the treatment of severe essential hypertension when the
drug cannot be given orally or when there is an urgent need to
lower blood pressure.
Hydralazine Hydrochloride Injection USP, 20 mg/mL, had U.S.
sales of approximately $63.4 million
for the 12 months ending March 31,
2016, according to IMS Health. Mylan's launch of this
product adds to the company's growing portfolio of more than 150
injectable products available to patients in the U.S. across a
broad array of therapeutic categories including oncology,
anti-infectives, anesthesia/pain management and cardiovascular.
Currently, Mylan has 263 ANDAs pending FDA approval representing
$109.5 billion in annual brand sales,
according to IMS Health. Forty-seven of these pending ANDAs are
potential first-to-file opportunities, representing $37.5 billion in annual brand sales, for the 12
months ending December 31, 2015,
according to IMS Health.
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 1,400 generic and branded pharmaceuticals,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS in the developing world depend.
We market our products in approximately 165 countries and
territories. Our global R&D and manufacturing platform includes
more than 50 facilities, and we are one of the world's largest
producers of active pharmaceutical ingredients. Every member of our
nearly 35,000-strong workforce is dedicated to creating better
health for a better world, one person at a time. Learn more at
mylan.com.
This press release includes statements that constitute
"forward-looking statements," including with regard to the
statement that Mylan's launch of this product adds to the company's
growing portfolio of more than 150 injectable products available to
patients in the U.S. across a broad array of therapeutic categories
including oncology, anti-infectives, anesthesia/pain management and
cardiovascular. 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
ability to develop, manufacture, and commercialize products; the
impact of competition and the use of legal, regulatory and
legislative strategies by competitors or other third parties to
delay or prevent our introduction of new products; changes in
economic and financial conditions; changes in third party
relationships; actions and decisions of healthcare and
pharmaceutical regulators, and changes in healthcare and
pharmaceutical laws and regulations, in the United States and abroad; 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.
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SOURCE Mylan N.V.