- Mayne Pharma’s (MYX) New Drug Application (NDA) for an oral contraceptive pill to prevent pregnancy has been accepted for review by the U.S. FDA
- The FDA is expecting to have the review completed by the first half of 2021
- If approved, this pill will be the first new oestrogen product introduced in the States in 50 years
- Additionally, Mayne Pharma is planning to file the pill with the Therapeutic Goods Administration in Australia later this year
- Mayne Pharma is up 4.73 per cent on the market and shares are trading for 38.8 cents each
Mayne Pharma’s (MYX) New Drug Application (NDA) for an oral contraceptive pill to prevent pregnancy has been accepted for review by the U.S. FDA.
The FDA (Food and Drug Administration) is expected to have the review complete by the first half of 2021.
“This is another important milestone for E4/DRSP and brings us one step closer to providing women in the U.S. with a new contraceptive that we believe will be effective, safe and well-tolerated,” CEO Scott Richards commented.
“We look forward to working with the FDA and Mithra during the ongoing review of our application. In parallel, we continue to advance our U.S. commercial strategy and infrastructure to ensure we are well-positioned to support the potential launch of E4/DRSP in the first half of calendar 2021,” he added.
E4/DRSP, which is developed by Mithra Pharmaceuticals, is an oral contraceptive pill that contains 15 milligrams of estetrol (E4) and three milligrams of drospirenone (DRSP).
Estetrol is a native oestrogen that is produced by the human foetal liver during pregnancy while drospirenone is used in birth control pills to prevent pregnancy.
If this pill is approved, then it will be the first contraceptive product containing estetrol and the first new oestrogen introduced into the United States in 50 years.
Additionally, Mayne Pharma has extended its partnership with Mithra to bring E4/DRSP to Australia and the company is planning to file it with the Therapeutic Goods Administration this year.
Mayne Pharma is up 4.73 per cent in mid-morning trade and shares are selling for 38.8 cents each at 10:33 am AEST.