HERTFORDSHIRE, England and
PITTSBURGH, March 29, 2017 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today commented on the status of its
abbreviated new drug application (ANDA) with the U.S. Food and Drug
Administration (FDA) for its generic version of GlaxoSmithKline's
Advair Diskus®.
In conjunction with Mylan's GDUFA goal date, the company
received a complete response letter from FDA regarding its ANDA for
generic Advair Diskus®. Mylan is in the process of reviewing this
response and will provide an update on its application as soon as
practicable once it has completed its review and discussed the
FDA's feedback with the agency.
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 market a
growing portfolio of approximately 7,500 products around the world,
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.
We are one of the world's largest producers of active
pharmaceutical ingredients. Every member of our more than
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.