Amneal Launches Generic Abiraterone Acetate Tablets, USP, 500 mg, Following ANDA Approval by FDA
Amneal Pharmaceuticals (NYSE: AMRX) announced FDA approval for a 500 mg strength of its Abiraterone Acetate Tablets, a generic version of Zytiga® for metastatic prostate cancer. This approval follows the existing 250 mg strength and allows for use in combination with Prednisone. Amneal has initiated commercialization for this additional strength, which could tap into the U.S. market valued at approximately $413 million annually, as reported by IQVIA™.
- FDA approval of 500 mg strength for Abiraterone Acetate Tablets enhances product portfolio.
- Immediate commercialization activities initiated, potentially increasing revenue.
- Adverse reactions reported include hypertension, hypokalemia, and increased mortality risk.
Amneal 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.
According 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
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.
See Package Insert (PI) for full prescribing information and complete safety information:
About Amneal
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.
Amneal 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.
The Company also owns
Forward-Looking Statements
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The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Amneal. A list and descriptions of these risks, uncertainties and other factors can be found in the Company’s most recently filed Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as supplemented by any subsequently filed Quarterly Reports on Form 10-Q. Copies of these filings are available online at www.sec.gov, www.amneal.com or upon request from the Company.
Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof, except as otherwise required by United States securities laws.
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FAQ
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