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Lead Product(s): Estetrol,Drospirenone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: E4/DRSP
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2020
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.
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Lead Product(s): Estetrol,Drospirenone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2020
Details:
Mayne Pharma has submitted a New Drug Application to the US FDA, seeking marketing authorisation for E4/DRSP.
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