Healthcare Industry News:  Teva Pharma 

Biopharmaceuticals Generics FDA Litigation

 News Release - May 15, 2014

Mylan Applauds Court's Ruling Dismissing Teva's Suit Against FDA on Copaxone(R)

PITTSBURGH, May 15, 2014 -- (Healthcare Sales & Marketing Network) -- Mylan Inc. (MYL) today commented on the ruling by the U.S. District Court for the District of Columbia against Teva in their suit against the U.S. Food and Drug Administration (FDA), which denied Teva's motion to block FDA from approving generic versions of Copaxone® and dismissed the case for lack of jurisdiction. Mylan had intervened in this suit in support of FDA.

Mylan CEO Heather Bresch commented, "Teva's suit against FDA was simply a desperate, last minute tactic, among others, to delay access to more affordable generic versions of Copaxone® for patients in the U.S. Following the Court's decision against Teva, we continue to see no barrier to FDA approval of Mylan's generic Copaxone following patent expiry, and we look forward to being able to launch this very important first generic product for multiple sclerosis at market formation."

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.

Source: Mylan

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