FDA Green Lights Generic Drug for Certain Patients with Prostate Cancer


Glenmark Pharmaceuticals has received FDA approval for abiraterone acetate tablets USP, 250 mg, a generic of Janssen's Zytiga tablets, 250 mg.1

Glenmark Pharmaceuticals has received FDA approval for abiraterone acetate tablets USP, 250 mg, a generic version of Janssen's Zytiga tablets, 250 mg.1

Abiraterone acetate tablets are a type of hormone therapy used in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have already received chemotherapy containing docetaxel.2

According to a 2015 study, the prevalence of mCRPC was 36,100 in the United States in 2009. A predictive model estimated that the prevalence of mCRPC will climb to 42,970 in 2020. Of the 168,290 prostate cancer-related deaths in 2009, 20.5% were attributed to mCRPC.3

The drug works by inhibiting specific enzymes in the adrenal glands, which are responsible for making androgens. Common adverse effects of the drug include fluid retention, increased triglycerides, and increased liver enzymes.2


  • Glenmark Pharmaceuticals received ANDA approval for Abiraterone Acetate Tablets USP, 250 mg [news release]. Mumbai, India; October 17, 2019: Glenmark Pharmaceuticals. https://www.glenmarkpharma.com/sites/default/files/Glenmark-received-ANDA-approval-for-Abiraterone-Acetate-Tablets-USP-250-mg.pdf. Accessed October 17, 2019.
  • Chemocare. Abiraterone Acetate, Chemocare.com. http://chemocare.com/chemotherapy/drug-info/abiraterone-acetate.aspx. Accessed October 17, 2019.
  • Scher H, Solo K, Valant J, et al. Prevalence of Prostate Cancer Clinical States and Mortality in the United States: Estimates Using Dynamic Progression Model. National Center for Biotechnology Information. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4603789/. Accessed October 17, 2019.

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