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 $413 million.
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:
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 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. For more information, visit www.amneal.com.
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995, as amended). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including, among other things, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy. Words such as “may,” “will,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “assume,” “continue,” and similar words are intended to identify estimates and forward-looking statements.
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.
EVP, Chief Financial Officer