American Regent`s Generic Potassium Phosphate Receives Approval in the U.S.
SHIRLEY, N.Y.--(BUSINESS WIRE)--American Regent, Inc., a Daiichi Sankyo Group company, today announced results from the phase 3 HEART-FID trial of INJECTAFER® (ferric carboxymaltose injection) for the treatment of iron deficiency in adult heart failure patients with reduced ejection fraction (HFrEF). While there was a numerical improvement in the hierarchical composite endpoint, the trial did not meet statistical significance on the primary endpoint, which was a hierarchical composite of death and heart failure hospitalization at 12 months and change from baseline to 6 months in the 6-minute walk test distance.1 The HEART-FID trial was designed as a single pivotal study instead of two based upon a special protocol assessment with the U.S. Food and Drug Administration (FDA). As a result, the study included a significance level for the final analysis of 0.0099 for the primary endpoint preserving the overall significance at 0.01.1 The safety profile of ferric carboxymaltose injection was consistent with previous reports with no new safety concerns identified.1
American Regent, Inc., a U.S. manufacturer of pharmaceuticals for human and veterinary use with manufacturing sites in New York and Ohio, today...
American Regent, Inc. and Provepharm Life Solutions are pleased to announce the availability of ProvayBlue® (methylene blue) Injection, USP in a 10...
MELVILLE, N.Y., March 31, 2022 /PRNewswire/ -- American Regent, Inc. is pleased to announce the launch of Selenious Acid Injection, USP in a new concentration and vial size. The Selenious Acid family now includes a 12 mcg/2 mL (6 mcg/mL of selenium) single-dose vial designed for pediatric and neonatal patients less than 7 kg. Selenious Acid Injection is a trace element indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
MELVILLE, N.Y., Feb. 3, 2022 /PRNewswire/ -- American Regent announces the introduction and availability of FDA-approved Vasopressin Injection, USP. Vasopressin is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
Vifor Pharma Group and its partner American Regent, Inc., a Daiichi Sankyo Group company, today announced that they have reached settlement agreements with Mylan Laboratories Ltd., and Sandoz, Inc., that resolve the patent litigation brought in response to Abbreviated New Drug Applications seeking approval by the U.S. Food and Drug Administration to market a generic version of Injectafer
MELVILLE, N.Y., Sept. 2, 2021 /PRNewswire/ -- American Regent, Inc. introduces FDA-approved Multrys™ (trace elements injection 4*, USP). Multrys™ is indicated in neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.2 View more product specific information.
SHIRLEY, N.Y., June 3, 2020 /PRNewswire/ -- American Regent announces the introduction and availability of Estradiol Valerate Injection, USP – AO Rated and therapeutically equivalent to Delestrogen®1,2.