HERTFORDSHIRE, England and
PITTSBURGH, March 28, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced the U.S. launch of Tramadol
Hydrochloride Extended-release Tablets USP, 100 mg, 200 mg and 300
mg, which is the generic version of Valeant's Ultram®
Extended-release 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 for
the management of moderate to moderately severe chronic pain in
adults who require around-the-clock treatment of their pain for an
extended period of time.
Tramadol Hydrochloride Extended-release Tablets USP, 100 mg, 200
mg and 300 mg, had U.S. sales of approximately $52.8 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.
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SOURCE Mylan N.V.