HERTFORDSHIRE, England and
PITTSBURGH, Aug. 10, 2015 /PRNewswire/ -- Mylan N.V. (Nasdaq:
MYL) today announced the U.S. launch of its Lidocaine Patch 5%,
which is the generic version of Endo Pharmaceutical's
Lidoderm®. 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 for relief
of pain associated with post-herpetic neuralgia.
Mylan CEO Heather Bresch said:
"We are very pleased to launch our Lidocaine Patch 5%. Mylan's
presentation of this product comes in the form of a thin,
lightweight patch, and offers patients a high quality, affordable
treatment option within the pain management space. We look forward
to continue innovating to meet unmet needs as we deliver on our
promise to bring complex, difficult-to-manufacture products to
market to benefit patients, providers and payors in the U.S. and
around the world."
Lidocaine Patch 5% had U.S. sales of approximately $1.1 billion for the 12 months ending
June 30, 2015, according to IMS
Health.
Currently, Mylan has 266 ANDAs pending FDA approval representing
$100 billion in annual brand sales,
according to IMS Health. Fifty of these pending ANDAs are
potential first-to-file opportunities, representing $33.4 billion in annual brand sales, for the 12
months ending December 31, 2014,
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 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.
This press release includes statements that constitute
"forward-looking statements," including with regard to sales of
products and the company's strategy, future growth and performance.
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: the impacts of competition; changes in economic and
financial conditions of the company's business; strategies by
competitors or other third parties to delay or prevent product
introductions; 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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/mylan-launches-generic-version-of-lidoderm-patch-300125881.html
SOURCE Mylan N.V.