`
`Mylan
`
`Aug 11, 2014
`Mylan Launches Generic Xeloda® Tablets
`
`
`PITTSBURGH, Aug. 11, 2014 /PRNewswire/ Mylan Inc. (Nasdaq: MYL) today announced that it has
`launched Capecitabine Tablets USP, 150 mg and 500 mg, the generic version of Genentech's Xeloda®
`Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its
`Abbreviated New Drug Application (ANDA) for this product, which is indicated as monotherapy, adjuvant
`therapy and combination therapy for certain types of breast, colon and colorectal cancers.(1)
`
`CEO Heather Bresch commented, "The approval of this product, one of a number of key approvals that
`had been pending with FDA, adds an important product to our broad and growing oncology franchise. We
`look forward to bringing a lower cost generic version of this product to patients."
`
`Capecitabine Tablets USP, 150 mg and 500 mg, had U.S. sales of approximately $773.8 million for the 12
`months ending June 30, 2014, according to IMS Health.
`
`Currently, Mylan has 296 ANDAs pending FDA approval representing $106 billion in annual brand sales,
`according to IMS Health. Fortythree of these pending ANDAs are potential firsttofile opportunities,
`representing $25.0 billion in annual brand sales, for the 12 months ending Dec. 31, 2013, according to
`IMS Health.
`
`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
`
`(1) Patients taking Capecitabine in combination with anticoagulation drugs, like warfarin and
`phenprocoumon, should have their coagulation response monitored frequently. Capecitabine is not
`indicated in patients with dihydropyrimidine dehydrogenase deficiency, severe renal insufficiency or a
`known hypersensitivity to capecitabine or any of its components.
`
`This press release includes statements that constitute "forwardlooking statements," including with regard
`to sales of products. These statements are made pursuant to the safe harbor provisions of the Private
`
`http://www.mylan.com/news/pressreleases/item?id=123242
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`IMMUNOGEN 2216, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`Mylan
`12/18/2014
`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.
`
`SOURCE Mylan Inc.
`
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`
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`http://www.mylan.com/news/pressreleases/item?id=123242
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`2/2
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`IMMUNOGEN 2216, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
`
`