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Caprelsa FDA Approval History

FDA Approved: Yes (First approved April 6, 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 timeline 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

Further information

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