HERTFORDSHIRE, England and
PITTSBURGH, Sept. 30, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced the U.S. launch of Metformin
Hydrochloride Extended-release Tablets USP, 500 mg and 1000 mg, a
generic version of Watson's
Fortamet®. 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 as an adjunct to diet
and exercise to improve glycemic control in adults with type 2
diabetes mellitus.(1)
Metformin Hydrochloride Extended-release Tablets USP, 500 mg and
1000 mg, had U.S. sales of approximately $770.3 million for the 12 months ending
July 31, 2016, according to IMS
Health.
Currently, Mylan has 240 ANDAs pending FDA approval representing
$98.2 billion in annual brand sales,
according to IMS Health. Forty-three of these pending ANDAs are
potential first-to-file opportunities, representing $34.4 billion in annual brand sales, for the 12
months ending June 30, 2016,
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 2,700 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 more than 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
40,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at mylan.com.
(1) Metformin hydrochloride has been associated with a rare, but
serious, metabolic complication called lactic acidosis, which can
be fatal. This condition may be associated with other conditions
including diabetes mellitus, renal insufficiency, congestive heart
failure, tissue hypoperfusion, hypoxemia and advanced age. Patients
should contact their healthcare providers with any questions if
taking metformin hydrochloride.
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SOURCE Mylan N.V.