Lead Product(s) : Estetrol,Drospirenone
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4/DRSP in the US
Details : 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.
Product Name : E4/DRSP
Product Type : Hormone
Upfront Cash : Inapplicable
June 24, 2020
Lead Product(s) : Estetrol,Drospirenone
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Estetrol,Drospirenone
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mayne Pharma Submits New Drug Application for E4/DRSP to the FDA
Details : Mayne Pharma has submitted a New Drug Application to the US FDA, seeking marketing authorisation for E4/DRSP.
Product Name : E4/DRSP
Product Type : Hormone
Upfront Cash : Inapplicable
April 16, 2020
Lead Product(s) : Estetrol,Drospirenone
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable