PITTSBURGH, Jan. 15, 2015 /PRNewswire/ -- Mylan Inc.
(Nasdaq: MYL) today announced the U.S. launch of its Lamivudine
Tablets, 100 mg, which is the generic version of GlaxoSmithKline's
Epivir-HBV®. 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 for the
treatment of chronic hepatitis B virus infection associated with
evidence of hepatitis B viral replication and active liver
inflammation.(1)
Lamivudine Tablets, 100 mg, had U.S. sales of approximately
$18.1 million for the 12 months
ending September 30, 2014, according
to IMS Health.
Currently, Mylan has 284 ANDAs pending FDA approval representing
$109.1 billion in annual brand sales,
according to IMS Health. Forty-four of these pending ANDAs are
potential first-to-file opportunities, representing $29.3 billion in annual brand sales, for the 12
months ending June 30, 2014,
according to IMS Health.
Mylan is a global pharmaceutical company committed to setting
new standards in health care. 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 1,300 generic pharmaceuticals and several
brand medications. In addition, we offer a wide range of
antiretroviral therapies, upon which approximately 40% of HIV/AIDS
patients in developing countries depend. We also operate one of the
largest active pharmaceutical ingredient manufacturers and
currently market products in approximately 140 countries and
territories. Our workforce of more than 25,000 people is dedicated
to improving the customer experience and increasing pharmaceutical
access to consumers around the world. Learn more at mylan.com.
(1) Use of Lamivudine has been associated with lactic acidosis
and fatty liver disease. Acute exacerbations of Hepatitis B have
occurred upon discontinuation. In patients with unrecognized
or untreated HIV, resistance may emerge while treating Hepatitis B
with Lamivudine.
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SOURCE Mylan Inc.