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    FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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              Mayne Pharma

              • Development Update

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              AUSTRALIA Australia

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              Chinaplas 2020

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              Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4/DRSP in the US

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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.

              Mayne Pharma

              • Development Update

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              AUSTRALIA Australia

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              Chinaplas 2020

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

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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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