Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Hydroxyprogesterone Caproate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 It has been withdrawn and cannot lawfully be distri...
Brand Name : Makena
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 06, 2023
Lead Product(s) : Hydroxyprogesterone Caproate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Hydroxyprogesterone Caproate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Makena
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 14, 2022
Lead Product(s) : Hydroxyprogesterone Caproate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Hydroxyprogesterone Caproate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Makena
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 26, 2021
Lead Product(s) : Hydroxyprogesterone Caproate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Hydroxyprogesterone Caproate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 bir...
Brand Name : Makena
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 14, 2020
Lead Product(s) : Hydroxyprogesterone Caproate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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