Mylan Inc. 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™.
Mylan
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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