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Label Changes for:

Ortho Evra (norelgestromin / ethinyl estradiol) transdermal system

July 2009

Changes have been made to the CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009


  • The term ‚Äúsignificant hypertension‚ÄĚ was replaced with actual blood pressure values


Elevated Blood Pressure
  • Providing more complete guidance to healthcare providers regarding use in women with hypertension


Clinical Trial Experience, Postmarketing Experience
  • editorial revisions to provide for use of MedDRA terminology and a more user-friendly format