HERTFORDSHIRE, England and
PITTSBURGH, July 6, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced the U.S. launch of Fenofibrate
Tablets USP, 40 mg and 120 mg, which is a generic version of
Santarus's Fenoglide®. 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 as
adjunctive therapy to diet to reduce elevated low-density
lipoprotein cholesterol, total cholesterol, Triglycerides, and
apolipoprotein B to increase high-density lipoprotein in adult
patients with primary hypercholesterolemia or mixed
dyslipidemia.
Fenofibrate Tablets USP, 40 mg and 120 mg, had U.S. sales of
approximately $28.6 million for the
12 months ending April 30, 2016,
according to IMS Health.
Currently, Mylan has 246 ANDAs pending FDA approval representing
$107.4 billion in annual brand sales,
according to IMS Health. Forty-three of these pending ANDAs are
potential first-to-file opportunities, representing $37.2 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
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.
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SOURCE Mylan N.V.