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    [{"orgOrder":0,"company":"AMAG Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AMAG Files Submission in Response To the FDA\u2019s Notice of Opportunity for a Hearing and Proposal To Withdraw Approval of Makena","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Covis Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"EPPPIC Study Reaffirms 17-OHPC for Reducing Early Preterm Birth in High-Risk, Singleton Pregnancies","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"LUXEMBOURG","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Covis Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Covis Pharma Provides Update on FDA Public Hearing for Makena","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"LUXEMBOURG","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"AMAG Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"}]

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    17-alpha-hydroxy-progesterone caproate

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              AMAG Pharmaceuticals

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              FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena

              Details:

              Makena (hydroxyprogesterone caproate) is a synthetic progestin. The drug was approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. It has been withdrawn and cannot lawfully be distributed.

              Lead Product(s): Hydroxyprogesterone Caproate

              Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Makena

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 06, 2023

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              Covis Pharma

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              Covis Pharma Provides Update on FDA Public Hearing for Makena

              Details:

              Makena, also referred to as 17 α-hydroxyprogesterone caproate, 17-OHPC, 17-HPC, or 17P, is the only FDA-approved treatment to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

              Lead Product(s): Hydroxyprogesterone Caproate

              Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Makena

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 14, 2022

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              Covis Pharma

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              EPPPIC Study Reaffirms 17-OHPC for Reducing Early Preterm Birth in High-Risk, Singleton Pregnancies

              Details:

              The publication presents the results of a meta-analysis of individual participant data from five trials examining injectable 17-alpha hydroxyprogesterone (17-OHPC), also referred to as MakenaÒ or generic alternatives.

              Lead Product(s): Hydroxyprogesterone Caproate

              Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Makena

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 26, 2021

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              AMAG Pharmaceuticals

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              AMAG Files Submission in Response To the FDA’s Notice of Opportunity for a Hearing and Proposal To Withdraw Approval of Makena

              Details:

              FDA’s Notice of Opportunity for a Hearing regarding the Agency’s proposal to withdraw approval for Makena also referred to as 17-OHPC, to reduce preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

              Lead Product(s): Hydroxyprogesterone Caproate

              Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Makena

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 14, 2020

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              Symbiotec Hydroxyprogesterone Caproate
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