Skip to Content

Caprelsa Approval History

  • FDA approved: Yes (First approved April 6th, 2011)
  • Brand name: Caprelsa
  • Generic name: vandetanib
  • Dosage form: Tablets
  • Company: AstraZeneca
  • Treatment for: Thyroid Cancer

Caprelsa (vandetanib) is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable (non-operable) locally advanced or metastatic disease.

Development History and FDA Approval Process for Caprelsa

Apr  6, 2011Approval FDA Approves Orphan Drug Vandetanib for Advanced Medullary Thyroid Cancer
Dec  3, 2010US FDA Advisory Committee Makes Recommendation on New Drug Application for Vandetanib in Advanced Medullary Thyroid Cancer
Sep 23, 2010US and EU Regulatory Submissions for Vandetanib in Advanced Medullary Thyroid Cancer Accepted for Review
Jul 30, 2009AstraZeneca Submits New Drug Applications for Zactima in Second-Line Advanced Non-Small Cell Lung Cancer

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.