Mayne Pharma (ASX:MYX)
has submitted a new drug application to the US Food and Drug Administration (FDA) its E4/DRSP oral contraceptive.
If approved, the drug is expected to be made available to patients in the US market in the first half of calendar 2021.
The oral contraceptive contains Estetrol (E4), a naturally occurring estrogen and 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.
Mayne Pharma’s CEO Scott Richards says the filing is a major milestone for Mayne Pharma and one step closer to making a new oral contraceptive that the company believes to be safe, effective and well-tolerated.
Shares in Mayne Pharma (ASX:MYX)
are trading 8.7 per cent higher at 38 cents.