8 January 2021 - - US-based Amneal Pharmaceuticals, Inc. (NYSE: AMRX) has received approval of an additional strength of 500 mg to its Abbreviated New Drug Application, from the US Food and Drug Administration for Abiraterone Acetate Tablets, USP, 250 mg and 500 mg, the company said.

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 commercialization activities upon the approval of the additional 500 mg strength.

According to IQVIA, a leading healthcare data and analytics provider, US annual sales for Abiraterone Tablets, USP, 500 mg, for the 12 months ended November 2020 were approximately USD 413m.

Important Safety Information includes the possibility of mineralocorticoid excess; adrenocortical insufficiency; hepatotoxicity; increased fractures and mortality in combination with radium Ra 223 dichloride; embryo-fetal toxicity; and hypoglycemia.

Reported adverse reactions include hypertension, hypokalemia, arthralgia and edema. Reported laboratory abnormalities include anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hyperglycemia, hypercholesterolemia and hypokalemia.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products.

The company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.