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# Amneal Pharma Generic Ortho Evra Approved
- URL: https://www.fdaweb.com/amneal-pharma-generic-ortho-evra-approved/
- Published: 2021-02-26T12:00:00.000Z
- Updated: 2026-09-14T16:48:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148761

FDA has approved an Amneal Pharmaceuticals ANDA for 150 mcg/day norelgestromin and 35 mcg/day ethinyl estradiol transdermal system, a generic copy of now-discontinued contraceptive Ortho Evra (Janssen Pharmaceuticals). As part of the approval, Amneal was granted 180 days marketing exclusivity. The product will be marketed under the proprietary name Zafemy. The company says the product will compete with Mylan’s equivalent product Xulane. U.S. annual sales for Xulane are about $332 million, it adds.