PITTSBURGH, April 16, 2014 /PRNewswire/ -- Mylan Inc. (MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched XULANE™ (Norelgestromin / Ethinyl Estradiol Transdermal System 150/35 mcg per day), the generic version of Janssen Pharmaceuticals Inc.'s ORTHO EVRA®* (Norelgestromin / Ethinyl Estradiol Transdermal System 150/35 mcg per day). This product is indicated for the prevention of pregnancy in women who elect to use a transdermal patch as a method of contraception. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.
Mylan CEO Heather Bresch commented: “Mylan is proud to continue expanding its portfolio of transdermal products through the launch of the first generic Ortho Evra Patch. Mylan’s XULANE (Norelgestromin / Ethinyl Estradiol Transdermal System 150/35 mcg per day), which provides women with a high quality, affordable treatment option, once again demonstrates Mylan’s commitment to bring to market difficult-to-develop and -manufacture medicines in support of our mission to expand access to high quality medicine.”
ORTHO EVRA had U.S. sales of approximately $152.9 million for the 12 months ending Dec. 30, 2013, according to IMS Health.
Currently, Mylan has 300 ANDAs pending FDA approval representing $104.5 billion in annual brand sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $25.4 billion in annual brand sales, for the 12 months ending December 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
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