HERTFORDSHIRE, England
and PITTSBURGH, Sept. 18, 2015
/PRNewswire/ -- Mylan N.V. (Nasdaq: MYL) today announced the
U.S. launch of Fluvastatin Sodium Extended-release Tablets, 80 mg,
which is the generic version of Novartis' Lescol XL®
Tablets. 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 to reduce elevated
total cholesterol, LDL-C, Apo B, and triglyceride, and increase
HDL-C in adults with primary hypercholesterolaemia and mixed
dyslipidaemia, as an adjunct to diet, when response to diet and
other non-pharmacological treatments (e.g. exercise, weight
reduction) is inadequate.
Fluvastatin Sodium Extended-release Tablets, 80 mg, had U.S.
sales of approximately $37.6 million
for the 12 months ending June 30,
2015, according to IMS Health.
Currently, Mylan has 262 ANDAs pending FDA approval representing
$99.3 billion in annual brand sales,
according to IMS Health. Fifty of these pending ANDAs are potential
first-to-file opportunities, representing $33.4 billion in annual brand sales, for the 12
months ending December 31, 2014,
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 around 1,400 generic pharmaceuticals and several brand
medications. In addition, we offer a wide range of antiretroviral
therapies, upon which nearly 50% of HIV/AIDS patients in developing
countries depend. We also operate one of the largest active
pharmaceutical ingredient manufacturers and currently market
products in about 145 countries and territories. Our workforce of
approximately 30,000 people 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.