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: vandetanib
Trade Name: CAPRELSA(r)
Date Designated: 10/21/2005
Orphan Designation: Treatment of patients with follicular thyroid carcinoma, medullary thyroid carcinoma, anaplastic thyroid carcinoma, and locally advanced and metastatic papillary thyroid carcinoma
Orphan Designation Status: Designated/Approved
Genzyme Corporation
500 Kendall Street
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: vandetanib
Trade Name: CAPRELSA(r)
Marketing Approval Date: 04/06/2011
Approved Labeled Indication: Treatment of asymptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease
Exclusivity End Date: 04/06/2018 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-