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Xtandi Approval History

  • FDA approved: Yes (First approved August 31st, 2012)
  • Brand name: Xtandi
  • Generic name: enzalutamide
  • Dosage form: Capsules
  • Company: Medivation Inc. and Astellas Pharma Inc.
  • Treatment for: Prostate Cancer

Xtandi (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.

Development History and FDA Approval Process for Xtandi

Aug 31, 2012Approval FDA Approves Xtandi for Late-Stage Castration-Resistant Prostate Cancer
May 22, 2012Medivation and Astellas Announce Submission of New Drug Application for Enzalutamide for the Treatment of Castration-Resistant Prostate Cancer in Patients Previously Treated with Chemotherapy

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