HERTFORDSHIRE, England and
PITTSBURGH, July 20, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced the U.S. launch of Rosuvastatin
Calcium Tablets, 5 mg, 10 mg, 20 mg and 40 mg, which is a generic
version of AstraZeneca's Crestor®. Mylan received final approval
from the U.S. Food and Drug Administration (FDA) for its
Abbreviated New Drug Application (ANDA) for this product.
Rosuvastatin Calcium Tablets are used in combination with diet
for the treatment of high triglycerides (hypertriglyceridemia) in
adults.
Rosuvastatin Calcium Tablets, 5 mg, 10 mg, 20 mg and 40 mg, had
U.S. sales of approximately $6.7
billion for the 12 months ending May
31, 2016, according to IMS Health.
Currently, Mylan has 245 ANDAs pending FDA approval representing
$101.6 billion in annual brand sales,
according to IMS Health. Forty-one of these pending ANDAs are
potential first-to-file opportunities, representing $30.8 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.