HERTFORDSHIRE, England, and
PITTSBURGH, Feb. 19, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced that its abbreviated new drug
application (ANDA) for fluticasone propionate 100, 250, 500 mcg and
salmeterol 50 mcg inhalation powder has been accepted for filing by
the U.S. Food and Drug Administration (FDA). The FDA provided Mylan
a GDUFA goal date of March 28, 2017.
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 CEO Heather Bresch said,
"The FDA's acceptance of our ANDA filing is an important
achievement for our generic Advair Diskus development program and
our respiratory franchise as a whole. Leading up to this milestone,
we held several discussions with FDA to provide input on and
solidify our understanding of the agency's expectations for the
development of the first AB-rated generic Advair Diskus product.
Our ongoing dialogue with FDA and this ANDA filing acceptance gives
us further confidence in the robustness of our clinical program and
reinforces our continued belief that Mylan will be the first to
bring to market an AB-rated, substitutable generic form of Advair
Diskus."
Mylan President Rajiv Malik
added, "The acceptance of our generic Advair Diskus ANDA filing
demonstrates, yet again, Mylan's leadership in bringing high
quality, affordable medicine to patients. I would like to thank our
generic Advair team around the world, especially our teams in the
U.K. and Ireland. We look forward
to now working with FDA through the approval process to bring this
very important product to patients."
Advair Diskus had U.S. sales of approximately $4.8 billion for the 12 months ending
Dec. 31, 2015, according to IMS
Health.
Currently, Mylan has 264 ANDAs pending FDA approval representing
$102.3 billion in annual brand sales,
according to IMS Health. Forty-eight of these pending ANDAs are
potential first-to-file opportunities, representing $35.4 billion in annual brand sales, for the 12
months ending June 30, 2015,
according to IMS Health.
About Mylan
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.
This press release includes statements that constitute
"forward-looking statements," including with regard to the GDUFA
goal date; Mylan's ongoing dialogue with FDA and this ANDA filing
acceptance giving Mylan further confidence in the robustness of its
clinical program and reinforces our continued belief that Mylan
will be the first to bring to market an AB-rated, substitutable
generic form of Advair Diskus; Mylan leading the way in bringing
high quality, affordable medicine to patients; bringing the product
to market; and working with FDA on the next phase of the approval
process. These statements are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Because such statements inherently involve risks and uncertainties,
actual future results may differ materially from those expressed or
implied by such forward-looking statements. Factors that could
cause or contribute to such differences include, but are not
limited to: strategies by competitors or other third parties to
delay or prevent product introductions; the effect of any changes
in our customer and supplier relationships and customer purchasing
patterns; other changes in third-party relationships; the impact of
competition; changes in the economic and financial conditions of
the businesses of Mylan; the scope, timing, and outcome of any
ongoing legal proceedings and the impact of any such proceedings on
our business; any regulatory, legal, or other impediments to our
ability to bring our products to market; actions and decisions of
healthcare and pharmaceutical regulators, and changes in healthcare
and pharmaceutical laws and regulations, in the United States and abroad; our ability to
protect our intellectual property and preserve intellectual
property rights; other uncertainties and matters beyond the control
of management; and the other risks detailed in the company's
filings with the Securities and Exchange Commission. The company
undertakes no obligation to update these statements for revisions
or changes after the date of this release.
ADVAIR and ADVAIR DISKUS are registered trademarks of Glaxo
Group Limited.
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SOURCE Mylan N.V.