HERTFORDSHIRE, England and
PITTSBURGH, Nov. 16, 2015 /PRNewswire/ -- Mylan N.V. (NASDAQ,
TASE: MYL), today announced the U.S. launch of Nevirapine
Extended-release Tablets, 100 mg, the generic version of Boehringer
Ingelheim's Viramune XR®. 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 in combination with other antiretroviral agents for the
treatment of HIV-1 infection in adults and in children 6 to less
than 18 years of age.(1) The launch adds to Mylan's growing
portfolio of ARV medicines across the globe, and represents the
company's continued commitment to stem the tide of HIV/AIDS.
Approximately 50% of those being treated for HIV/AIDS in the
developing world, for example, rely on a Mylan product.
Nevirapine Extended-release Tablets, 100 mg, had U.S. sales of
approximately $67 thousand for the 12
months ending Sept. 30, 2015,
according to IMS Health.
Currently, Mylan has 253 ANDAs pending FDA approval representing
$100.8 billion in annual brand sales,
according to IMS Health. Fifty of these pending ANDAs are potential
first-to-file opportunities, representing $36.1 billion in annual brand sales, for the 12
months ending June 30, 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 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.
(1) Severe, life-threatening, and in some cases fatal liver
toxicity and skin reactions have been reported with the use of
Nevirapine Extended-release tablets. Monitoring by your healthcare
provider is essential during the first 18 weeks of therapy.
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SOURCE Mylan N.V.