HERTFORDSHIRE, England and
PITTSBURGH, Jan. 11, 2016 /PRNewswire/ -- In advance of its
upcoming presentation at the J.P. Morgan Annual Healthcare
Conference tomorrow, Mylan N.V. (NASDAQ, TASE: MYL) today confirmed
that it submitted its abbreviated new drug application (ANDA) for
fluticasone propionate 100, 250, 500 mcg and salmeterol 50 mcg
inhalation powder to the U.S. Food and Drug Administration (FDA) in
Dec. 2015. This product is the
generic version of GlaxoSmithKline's Advair Diskus®, which is
indicated for the treatment of asthma and
the maintenance treatment of airflow obstruction and reducing
exacerbations in patients with chronic obstructive pulmonary
disease (COPD).
Mylan will provide appropriate updates as the FDA process
unfolds.
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.
Advair® is a registered trademark of GlaxoSmithKline.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/mylan-confirms-fda-submission-of-anda-for-generic-advair-diskus-300202571.html
SOURCE Mylan N.V.