Mayne Pharma Submits New Drug Application For E4/DRSP to the FDA

16 April 2020, Adelaide Australia and Liege, Belgium – Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals SA (Euronext Brussels: MITRA) today announced that Mayne Pharma has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA), seeking marketing authorisation for E4/DRSP, a combined oral contraceptive indicated for the prevention of pregnancy in women. 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.