PITTSBURGH, May 30, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today commented on the decision by the United States District Court for the Northern District of West Virginia denying Mylan’s request for an injunction in its suit against the U.S. Food and Drug Administration (FDA), challenging the agency’s decision regarding generic drug marketing exclusivity on Celecoxib Capsules, the generic version of Pfizer’s Celebrex®.
Mylan continues to believe that FDA seriously erred in its decision regarding eligibility for 180 days of exclusivity on Celecoxib. Mylan will review all of its options, including filing an expedited appeal in the United States Court of Appeals for the Fourth Circuit.
Mylan expects to receive final approval on the 50 mg strength of Celecoxib capsules imminently and has received tentative approval from FDA on all Celecoxib strengths.
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.
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