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: vosoritide
Trade Name: Voxzogo
Date Designated: 01/17/2013
Orphan Designation: Treatment of achondroplasia
Orphan Designation Status: Designated/Approved
BioMarin Pharmaceutical, Inc.
105 Digital Drive
Novato, California 94949
United States

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

Marketing approved:

1 Generic Name: vosoritide
Trade Name: Voxzogo
Marketing Approval Date: 11/19/2021
Approved Labeled Indication: To increase linear growth in pediatric patients with achondroplasia who are 5 years of age and older with open epiphyses
Exclusivity End Date: 11/19/2028 
Exclusivity Protected Indication* :  To increase linear growth in pediatric patients with achondroplasia who are 5 years of age and older with open epiphyses
2 Generic Name: vosoritide
Trade Name: Voxzogo
Marketing Approval Date: 10/20/2023
Approved Labeled Indication: to increase linear growth in pediatric patients with achondroplasia with open epiphyses
Exclusivity End Date: 10/20/2030 
Exclusivity Protected Indication* :  to increase linear growth in pediatric patients less than 5 years of age with achondroplasia with open epiphyses
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-