Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: hydroxyprogesterone caproate
Trade Name: Makena
Date Designated: 01/25/2007
Orphan Designation: Prevention of preterm birth in singleton pregnancies
Orphan Designation Status: Designated/Approved
AMAG Pharma USA, Inc.
1100 Winter Street
Waltham, Massachusetts 02154
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: hydroxyprogesterone caproate
Trade Name: Makena
Marketing Approval Date: 02/03/2011
Approved Labeled Indication: To reduce the risk of preterm birth in women with singleton pregnancy who have a history of singleton spontaneous preterm birth
Exclusivity End Date: 02/03/2018 
Exclusivity Protected Indication* :  
2 Generic Name: hydroxyprogesterone caproate
Trade Name: Makena
Marketing Approval Date: 02/14/2018
Approved Labeled Indication: Makena auto-injector for subcutaneous injection is indicated to reduce the risk of preterm birth in women with singleton pregnancy who have a history of singleton spontaneous preterm birth.
Exclusivity End Date: N/A  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-