> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Mayne Pharma NDA for New Contraceptive
- URL: https://www.fdaweb.com/mayne-pharma-nda-for-new-contraceptive/
- Published: 2020-04-16T12:00:00.000Z
- Updated: 2026-09-14T16:11:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146584

Mayne Pharma has filed an NDA for E4/DRSP (estetrol and drospirenone), a combined oral contraceptive indicated for preventing pregnancy. The company describes the novel, next-generation oral contraceptive as containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg. E4 is a naturally occurring estrogen that is produced by the human fetal liver during pregnancy, Mayne says, adding that its development and manufacturing partner Mithra can synthesize E4 using its complex plant-based production process. The company expects approval in the first half of 2021.