Regulatory Sources
U.S. Food and Drug Administration / DailyMed
Current U.S. labeling provides information on approved indications, dosing, administration, hepatic impairment, warnings, adverse reactions and interactions.
European Medicines Agency
The EMA EPAR and product information for Zytiga describe European indications, dosing, food restrictions and safety information.
Clinical and educational sources
National Cancer Institute
NCI provides educational information about androgen synthesis inhibitors and prostate-cancer treatment.
Historical development sources
FDA documentation for the original Zytiga application identifies the historical applicant and Cougar Biotechnology relationship.
Product-specific sources
Available medicine listings identify Abirapro 250 mg as a Glenmark Pharmaceuticals Ltd. product containing abiraterone acetate.
Source-use statement
Regulatory sources should take priority over commercial product listings for medical and prescribing information. Product-specific manufacturing and authorization claims should be confirmed against current packaging and official regulatory documentation.