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# Mayne NDA Accepted for Novel Contraceptive
- URL: https://www.fdaweb.com/mayne-nda-accepted-for-novel-contraceptive/
- Published: 2020-06-24T12:00:00.000Z
- Updated: 2026-09-14T16:19:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147079

FDA has accepted for review a Mayne Pharma Group NDA for E4/DRSP (estetrol and drospirenone) for preventing pregnancy. The submission includes data from two Phase 3 clinical studies conducted in more than 3,725 women aged 16 to 50 years. A review action is expected in the first half of 2021.

Mayne describes E4/DRSP as a novel combined oral contraceptive pill containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP). E4 is a naturally occurring estrogen that is produced by the human fetal liver during pregnancy, it says. “Following more than 20 years of research and development, Mayne Pharma’s development and manufacturing partner, Mithra, can synthesise E4 at scale through a complex plant-based production process,” it explains.