PITTSBURGH, April 16, 2014 /PRNewswire/ -- Mylan Inc.
(Nasdaq: 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
SOURCE Mylan Inc.