Amneal Pharmaceuticals announced that it has received approval of an additional strength of 500 mg to its Abbreviated New Drug Application (ANDA), from the US Food and Drug Administration (FDA) for Abiraterone Acetate Tablets, USP, 250 mg and 500 mg. This ANDA is approved for its use in combination with Prednisone. Abiraterone Acetate Tablets, USP, 250 mg and 500 mg, are the generic version of Zytiga for treatment of metastatic prostate cancer. Amneal immediately initiated commercialisation activities upon the approval of the additional 500 mg strength.
According to IQVIA, US annual sales for Abiraterone Tablets, USP, 500 mg, for the 12 months ended November 2020 were approximately $413 million.