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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

DateArticle
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

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