Search Orphan Drug Designations and Approvals
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Generic Name: | vandetanib | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
Genzyme Corporation 500 Kendall Street Cambridge, Massachusetts 02142 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | vandetanib |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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