Posted by Michael Wonder on 14 Jan 2021
Amneal launches generic abiraterone acetate 500 mg tablets following ANDA approval by FDA
8 January 2021 - Amneal Pharmaceuticals announced that it has received approval of an additional strength of 500 mg to its abbreviated new drug application, from the U.S. FDA for Abiraterone acetate 250 mg and 500 mg tablets.
This abbreviated new drug application 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.
