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: sorafenib
Trade Name: Nexavar
Date Designated: 12/12/2011
Orphan Designation: Treatment of medullary thyroid cancer, anaplastic thyroid cancer, and recurrent or metastatic follicular or papillary thyroid cancer
Orphan Designation Status: Designated/Approved
Bayer HealthCare Pharmaceuticals, Inc.
100 Bayer Blvd.
PO Box 915
Whippany, New Jersey 07981
United States

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

Marketing approved:

1 Generic Name: sorafenib
Trade Name: Nexavar
Marketing Approval Date: 11/22/2013
Approved Labeled Indication: Treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DCT) that is refractory to radioactive iodine treatment.
Exclusivity End Date: 11/22/2020 
Exclusivity Protected Indication* :  Treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DCT) that is refractory to radioactive iodine treatment.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-