Ortho Evra (norelgestromin/ethinyl estradiol) Information

FDA has approved changes to the Ortho Evra label to include the results of an additional epidemiology study designed to evaluate the risk of developing serious blood clots, also known as venous thromboembolism (VTE), among women aged 15-44 when using Ortho Evra.

• FDA News: FDA Approves Update to Label on Birth Control Patch (1/18/2008)

• Questions and Answers (1/18/2008)

• Labeling [PDF] (approved 1/18/2008)

Historical  Information

• Questions and Answers (9/20/2006)

• FDA News: FDA Updates Labeling for Ortho Evra Contraceptive Patch (11/10/2005)

• Questions and Answers (11/10/2005)

• Approved Labeling and Approval Letters through Drugs@FDA