Amneal Launches Generic Abiraterone Acetate Tablets, USP, 500 mg, Following ANDA Approval by Food and drug administration
This ANDA is authorized for its use in mix with Prednisone. Abiraterone Acetate Tablets, USP, 250 mg and 500 mg, are the generic model of Zytiga® for treatment of metastatic prostate cancer. Amneal right away initiated commercialization functions on the acceptance of the extra 500 mg energy.
In accordance to IQVIA™, a top healthcare info and analytics supplier, US annual profits for Abiraterone Tablets, USP, 500 mg, for the 12 months finished November 2020 ended up about $413 million.
Essential Protection Information and facts includes the possibility of mineralocorticoid extra adrenocortical insufficiency hepatotoxicity greater fractures and mortality in mixture with radium Ra 223 dichloride embryo-fetal toxicity and hypoglycemia.
Documented adverse reactions include hypertension, hypokalemia, arthralgia and edema. Noted laboratory abnormalities consist of anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hyperglycemia, hypercholesterolemia and hypokalemia.
See Bundle Insert (PI) for full prescribing facts and complete basic safety details.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a absolutely-built-in pharmaceutical company targeted on the growth, manufacturing and distribution of generic and specialty drug products and solutions. The Organization has operations in North The united states, Asia, and Europe, doing work with each other to provide superior-excellent medicines to people generally inside of the United States.
Resource: Amneal Prescription drugs