Skip to Content

Zytiga Approval History

  • FDA approved: Yes (First approved April 28th, 2011)
  • Brand name: Zytiga
  • Generic name: abiraterone
  • Dosage form: Tablets
  • Company: Centocor Ortho Biotech Inc.
  • Treatment for: Prostate Cancer

Zytiga (abiraterone acetate) is a CYP17 inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer.

Development History and FDA Approval Process for Zytiga

Feb  8, 2018Approval Zytiga (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer
Dec 10, 2012Approval FDA Expands Zytiga’s Use for Late-Stage Prostate Cancer
Apr 28, 2011Approval FDA Approves Zytiga for Late-Stage Prostate Cancer
Dec 21, 2010Centocor Ortho Biotech Inc. Announces NDA Submission for Abiraterone Acetate for the Treatment of Metastatic Advanced Prostate 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.