PITTSBURGH, Aug. 19, 2014 /PRNewswire/ -- Mylan Inc.
(Nasdaq: MYL) announced that its business Mylan Institutional has
launched Dexmedetomidine Hydrochloride Injection, 100 mcg
(base)/mL, packaged in 200 mcg (base)/2 mL Single-dose Vials, which
is therapeutically equivalent to Hospira's Precedex™. Mylan
yesterday 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 the sedation of
non-intubated patients prior to and/or during surgical and other
procedures, and began shipping immediately.
Mylan CEO Heather Bresch
commented: "Mylan's launch of a therapeutically equivalent version
of Precedex Injection, another of a number of key approvals that
had been pending with FDA, represents an important addition to
Mylan's injectables portfolio and growing line of products in the
anesthesia and pain management category. As we continue to bring a
high quality, reliable supply of injectable products to the U.S.
market, Mylan looks forward to delivering on its promise of
providing quality medicine and service excellence in the
increasingly important institutional space."
Dexmedetomidine Hydrochloride Injection, 100 mcg (base)/mL,
packaged in 200 mcg (base)/2 mL Single-dose Vials, had U.S. sales
of approximately $156.2 million for
the 12 months ending June 30, 2014,
according to IMS Health.
Currently, Mylan has 295 ANDAs pending FDA approval representing
$105.8 billion in annual sales,
according to IMS Health. Forty-three of these pending ANDAs are
potential first-to-file opportunities, representing $25.0 billion in annual brand sales, for the 12
months ending December 31, 2013,
according to IMS Health.
Mylan is a global pharmaceutical company committed to setting
new standards in health care. 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 1,300 generic pharmaceuticals and several
brand medications. In addition, we offer a wide range of
antiretroviral therapies, upon which approximately 40% of HIV/AIDS
patients in developing countries depend. We also operate one of the
largest active pharmaceutical ingredient manufacturers and
currently market products in approximately 140 countries and
territories. Our workforce of more than 20,000 people is dedicated
to improving the customer experience and increasing pharmaceutical
access to consumers around the world. But don't take our word for
it. See for yourself. See inside. mylan.com
This press release includes statements that constitute
"forward-looking statements," including with regard to sales of
products. 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; risks inherent in legal and
regulatory processes; 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.
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SOURCE Mylan Inc.