Business
Amneal Launches Generic Abiraterone Acetate Tablets, USP, 500 mg, Following ANDA Approval by FDA
BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) announced that it has received approval of an
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":" BRIDGEWATER, N.J.--(BUSINESS WIRE)--\nAmneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) announced that it has received approval of an additional strength of 500 mg to its Abbreviated New Drug Application (ANDA), from the U.S. 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 commercialization activities upon the approval of the additional 500 mg strength.\n\nAccording to IQVIA™, a leading healthcare data and analytics provider, U.S. annual sales for Abiraterone Tablets, USP, 500 mg, for the 12 months ended November 2020 were approximately $413 million.\n\nImportant 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.\n\nReported adverse reactions include hypertension, hypokalemia, arthralgia and edema. Reported laboratory abnormalities include anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hyperglycemia, hypercholesterolemia and hypokalemia.\n\nSee Package Insert (PI) for full prescribing information and complete safety information:\n\nhttps://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=48ce18c7-5311-40cb-8903-104eb89b32e8#section-4\n\nAbout Amneal\n\nAmneal 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.\n\nAmneal has an extensive portfolio of approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.\n\nThe Company also owns 65% of AvKAR...