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Yonsa FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved May 22, 2018)
Brand name: Yonsa
Generic name: abiraterone acetate
Dosage form: Tablets
Company: Sun Pharmaceutical Industries Inc.
Treatment for: Prostate Cancer

Yonsa (abiraterone acetate) is an ultramicrosize formulation of the oral CYP17 inhibitor abiraterone acetate (approved as Zytiga) used in combination with methylprednisolone for the treatment of metastatic castration-resistant prostate cancer.

To avoid substitution errors and overdose, please be aware that Yonsa tablets may have different dosing and food effects compared to other abiraterone acetate products.

Development timeline for Yonsa

May 23, 2018Approval Sun Pharma Announces FDA Approval of Yonsa (abiraterone acetate) to Treat Metastatic Castration-Resistant Prostate Cancer
Jul 20, 2017Churchill Pharmaceuticals Announces NDA Filing Acceptance for Yonsa by the U.S. FDA
May 23, 2017Churchill Pharmaceuticals Announces Submission of NDA for Yonsa (abiraterone acetate) Novel Oral Formulation of Prostate Cancer Treatment

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.