HERTFORDSHIRE, England and
PITTSBURGH, Dec. 29, 2015 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced the U.S. launch of Linezolid
Tablets, 600 mg, which is the generic version of Pfizer's
Zyvox® 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 in
adults and children for the treatment of certain infections caused
by susceptible Gram-positive bacteria.
Linezolid Tablets, 600 mg, had U.S. sales of approximately
$457.8 million for the 12 months
ending Sept. 30, 2015, according to
IMS Health.
Currently, Mylan has 269 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 $35.6 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 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 more than
30,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at mylan.com.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/mylan-launches-generic-zyvox-tablets-300197348.html
SOURCE Mylan N.V.