BRIDGEWATER, N.J.–(Business enterprise WIRE)–Amneal Prescription drugs, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) announced that it has obtained acceptance of an supplemental toughness of 500 mg to its Abbreviated New Drug Application (ANDA), from the U.S. Food stuff and Drug Administration (Fda) for Abiraterone Acetate Tablets, USP, 250 mg and 500 mg. This ANDA is authorized for its use in mix with Prednisone. Abiraterone Acetate Tablets, USP, 250 mg and 500 mg, are the generic variation of Zytiga® for therapy of metastatic prostate most cancers. Amneal right away initiated commercialization pursuits on the approval of the added 500 mg energy.
According to IQVIA™, a major health care details and analytics service provider, U.S. yearly product sales for Abiraterone Tablets, USP, 500 mg, for the 12 months ended November 2020 were approximately $413 million.
Important Basic safety Info consists of the chance of mineralocorticoid excessive adrenocortical insufficiency hepatotoxicity improved fractures and mortality in mix with radium Ra 223 dichloride embryo-fetal toxicity and hypoglycemia.
Claimed adverse reactions involve hypertension, hypokalemia, arthralgia and edema. Reported laboratory abnormalities consist of anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hyperglycemia, hypercholesterolemia and hypokalemia.
See Package Insert (PI) for comprehensive prescribing info and complete protection information:
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a totally-integrated pharmaceutical organization concentrated on the growth, production and distribution of generic and specialty drug products. The Firm has operations in North The usa, Asia, and Europe, operating jointly to convey superior-quality medicines to individuals generally within just the United States.
Amneal has an extensive portfolio of approximately 250 product or service households and is expanding its portfolio to incorporate complicated dosage kinds, which includes biosimilars, in a broad array of therapeutic parts. The Corporation also markets a portfolio of branded pharmaceutical merchandise through its Specialty phase focused principally on central anxious system and endocrine conditions.
The Firm also owns 65% of AvKARE. AvKARE offers pharmaceuticals, health-related and surgical goods and providers generally to governmental companies, mostly focused on serving the Office of Protection and the Division of Veterans Affairs. AvKARE is also a packager and wholesale distributor of prescription drugs and natural vitamins to its retail and institutional shoppers who are found all through the United States focused largely on featuring 340b-experienced entities products and solutions to provide consistency in treatment and pricing. For additional facts, go to www.amneal.com.
Ahead-On the lookout Statements
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The reader is cautioned not to count on these ahead-wanting statements. These forward-hunting statements are based mostly on current expectations of long term functions. If the fundamental assumptions verify inaccurate or known or unknown risks or uncertainties materialize, genuine success could change materially from the expectations and projections of Amneal. A listing and descriptions of these risks, uncertainties and other things can be found in the Company’s most a short while ago submitted 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 out there on the internet at www.sec.gov, www.amneal.com or on ask for from the Organization.
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EVP, Chief Monetary Officer