Posted by Michael Wonder on 16 Apr 2020
Mayne Pharma submits new drug application for E4/DRSP to the FDA
16 April 2020 - Mayne Pharma and Mithra Pharmaceuticals today announced that Mayne Pharma has submitted a new drug application to the US FDA, seeking marketing authorisation for E4/DRSP, a combined oral contraceptive indicated for the prevention of pregnancy.
If approved by the FDA, E4/DRSP is expected to be made available to patients in the US market in the first half of calendar 2021.
E4/DRSP is a novel, next generation oral contraceptive containing Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg. E4 is a naturally occurring oestrogen that is produced by the human fetal 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.
