PITTSBURGH, Sept. 8, 2014 /PRNewswire/ -- Mylan Inc.
(Nasdaq: MYL) today commented on a ruling by the U.S. District
Court for the District of Maryland
related to its product, Dexmedetomidine Hydrochloride Injection,
100 mcg (base)/mL, packaged in 200 mcg (base)/2 mL Single-dose
Vials, which was approved by the U.S. Food and Drug Administration
(FDA) as therapeutically equivalent to Hospira Inc.'s
Precedex™.
On Sept. 5, the Court granted
summary judgment in favor of Mylan, Par Sterile Products and FDA,
and lifted a previously entered temporary restraining order against
those parties related to generic Precedex.
As a result of the ruling, Mylan is free to immediately resume
distribution of its generic Precedex to customers.
This press release includes statements that constitute
"forward-looking statements," including with regard to litigation
and 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.
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
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SOURCE Mylan Inc.