Mylan Pharmaceuticals has launched XULANET (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.