API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
EU WC
Listed Suppliers
0
USA (Orange Book)
Europe
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
Annual Reports
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 It has been withdrawn and cannot lawfully be distributed.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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2023
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 2022
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 26, 2021
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2020