HERTFORDSHIRE, England and
PITTSBURGH, Aug. 18, 2015 /PRNewswire/ -- Mylan N.V. (Nasdaq:
MYL) today commented on a warning letter issued by the U.S. Food
and Drug Administration (FDA) on Aug. 6,
2015, relating to its Agila Specialty Formulation Facility
(SFF), Sterile Product Division (SPD), and Onco Therapies Limited
(OTL) sites in India. This action
follows inspections of the three sites by FDA as much as a year
ago, in 2014 and February 2015, which
Mylan has disclosed previously.
This Agency action has no material impact on Mylan's business or
its previously announced full year earnings guidance.
Mylan CEO Heather Bresch
commented, "Since Mylan acquired the Agila injectables businesses
in December 2013 to create a leading
global injectables platform, we have been taking extensive action
to integrate the Agila business into Mylan's One Quality Standard,
and to ensure our leading position as a high quality, reliable
source of injectables for the long term. As part of this ongoing
process, we have a deep and unwavering commitment to quality
everywhere we operate. We have been and will continue to work
diligently to address all of the FDA's observations and have made
important progress."
This press release includes statements that constitute
"forward-looking statements," including with regard FDA actions,
our Agila injectables business, and our integration, enhancement,
and remediation efforts. 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: risks inherent in
legal and regulatory processes; 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.
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 around 1,400 generic pharmaceuticals and several brand
medications. In addition, we offer a wide range of antiretroviral
therapies, upon which nearly 50% of HIV/AIDS patients in developing
countries depend. We also operate one of the largest active
pharmaceutical ingredient manufacturers and currently market
products in about 145 countries and territories. Our workforce of
approximately 30,000 people 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.