HERTFORDSHIRE, England and
PITTSBURGH, June 18, 2018 /PRNewswire/ -- Global
pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced the
U.S. launch of Bivalirudin for Injection, 250 mg single-dose vial,
a generic version of Angiomax® from The Medicines
Company. The product is a direct thrombin inhibitor indicated for
use as an anticoagulant in patients.
Mylan is offering Bivalirudin for Injection, 250 mg single-dose
vial, to its hospital and institutional customers after an
Abbreviated New Drug Application (ANDA) for the product was
approved by the U.S. Food and Drug Administration (FDA).
Bivalirudin for Injection is indicated for use as an
anticoagulant in patients:
- with unstable angina undergoing percutaneous transluminal
coronary angioplasty;
- undergoing percutaneous coronary intervention (PCI) with
provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as in the
REPLACE-2 study;
- or with, or at risk of, heparin-induced thrombocytopenia (HIT)
or heparin induced thrombocytopenia and thrombosis syndrome
(HITTS), undergoing PCI.
It is intended for use in these indications with aspirin.
The safety and effectiveness have not been established in patients
with acute coronary syndromes who are not undergoing PTCA or
PCI.
Bivalirudin for Injection, 250 mg single-dose vial, had U.S.
sales of approximately $106 million
for the 12 months ending March 31,
2018, according to IQVIA.
Currently, Mylan has 199 ANDAs pending FDA approval representing
approximately $88.5 billion in annual
brand sales, according to IQVIA. Forty-five of these pending ANDAs
are potential first-to-file opportunities, representing
$45.5 billion in annual brand sales,
for the 12 months ending December 31,
2017, according to IQVIA.
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 approximately 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.