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Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4/DRSP in the US

June 24, 2020 / PR Newswire

Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the New Drug Application (NDA) for E4/DRSP to prevent pregnancy has been accepted for review by the US Food and Drug Administration (FDA). The FDA is expected to complete its review in the first half of calendar 2021.

Developed by Mithra Pharmaceuticals SA (Mithra), E4/DRSP is 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 foetal liver during pregnancy. 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.