HERTFORDSHIRE, England and
PITTSBURGH, April 6, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced the U.S. launch of Lamivudine
Tablets USP, 150 mg and 300 mg, which is the generic version of
ViiV Healthcare's Epivir® Tablets. Mylan received final approval
from the U.S. Food and Drug Administration (FDA) for its
Abbreviated New Drug Application (ANDA) for this product.
Lamivudine Tablets is a nucleoside analogue reverse transcriptase
inhibitor indicated in combination with other antiretroviral agents
for the treatment of HIV‑1 infection.(1)
Lamivudine Tablets USP, 150 mg and 300 mg, had U.S. sales of
approximately $27.1 million for the
12 months ending Dec. 31, 2015,
according to IMS Health.
Currently, Mylan has 265 ANDAs pending FDA approval representing
$110.3 billion in annual brand sales,
according to IMS Health. Forty-eight of these pending ANDAs are
potential first-to-file opportunities, representing $38.3 billion in annual brand sales, for the 12
months ending Dec. 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 nearly 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 nearly
35,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at mylan.com.
(1) Use of Lamivudine has been associated with lactic acidosis
and fatty liver disease. In patients who are co-infected with
hepatitis B virus and HIV-1, severe acute exacerbations of
Hepatitis B have occurred upon discontinuation of lamivudine.
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SOURCE Mylan N.V.