Court Grants Summary Judgment in Favor of Mylan and FDA Related to Generic Precedex(TM)
Mylan Free to Immediately Resume Distribution of Its Generic Precedex Product
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.