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Zytiga FDA Approval History

FDA Approved: Yes (First approved April 28, 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 timeline for Zytiga

DateArticle
Apr 12, 2023ESSA Pharma Announces Clinical Trial Support Agreement with Janssen to Evaluate EPI-7386 Combinations in Patients with Prostate Cancer
Jan  5, 2023Positive Top-line Results from Pivotal Phase 3 Trial of TAVT-45 for the Treatment of Metastatic Prostate Cancer
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

See also

Zytiga (abiraterone) Consumer information

Further information

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