Renal Business Today

Feraheme

Canada Approves Feraheme to Treat CKD Patients

LEXINGTON, Mass.—Health Canada, on Dec. 8 granted marketing approval to AMAG Pharmaceuticals and Takeda Canada for the iron drug Feraheme. ...More
December 12, 2011
Posted in News, Business, Clinical & Pharma, Government & Regulation
AMAG Updates Feraheme Label

LEXINGTON, Mass.—AMAG Pharmaceuticals announced June 21 that it has updated the product label for Feraheme (ferumoxytol) Injection for Intravenous (IV) use. ...More
June 21, 2011
Posted in News, Clinical & Pharma, Government & Regulation
FDA Approves CMOs to Manufacture Feraheme

LEXINGTON, Mass.—The U.S. Food and Drug Administration (FDA) has approved two second source contract manufacturing organizations (CMO) to manufacture AMAG Pharmaceutical’s Feraheme® (ferumoxytol) Injection for Intravenous (IV) use. ...More
May 26, 2011
Posted in News, Business, Government & Regulation
AMAG Increases Revenues, Narrows Losses in 2010

LEXINGTON, Mass.—AMAG Pharmaceuticals increased its revenues in 2010 while also reducing its losses, according to the company, which manufactures the iron drug Feraheme. ...More
March 1, 2011
Posted in News, Business
AMAG Updates Feraheme Label

LEXINGTON, Mass.—AMAG Pharmaceuticals said Nov. 29 that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding an update to the product label for Feraheme Injection for intravenous (IV) use. ...More
November 29, 2010
Posted in News, Business, Clinical & Pharma, Government & Regulation
AMAG Reports Safety Issues with Feraheme, Cuts Workforce

AMAG Pharmaceuticals has reported potential safety issues with its iron management drug Feraheme and has decided to cut 24 percent of its workforce in an effort to restructure the company, the company announced in a news release. ...More
November 1, 2010
Posted in Blog, Clinical & Pharma, Government & Regulation
FDA Warns AMAG Over Drug Websites

The U.S. Food and Drug Administration (FDA) warned AMAG Pharmaceuticals in an Oct. 18 letter about allegedly misleading drug information on its websites. ...More
October 27, 2010
Posted in Blog, Government & Regulation
Use of Anemia Drugs in CKD Stabilizing

EXTON, Pa.— The use of erythropoietin-stimulating agents (ESAs) in patients with chronic kidney disease not on dialysis (CKD-ND) is showing signs of stabilization, according to the latest survey released by BioTrends Research. ...More
October 27, 2010
Posted in News, Clinical & Pharma, Practice Management
Survey: Anemia Managers Targeting Lower Hemoglobin

EXTON, Pa.— In the dialysis and chronic kidney disease non-dialysis (CKD-ND) settings, holding erythropoiesis-stimulating agents (ESAs) at lower hemoglobin levels and lower hemoglobin targets are the most common recent changes reported by anemia managers, according to a new ...More
September 28, 2010
Posted in News, Practice Management
AMAG, FDA To Meet About Feraheme Safety Issues

CAMBRIDGE, Mass.—AMAG Pharmaceuticals was forced to pull out of a business conference due to a safety meeting it must have with the U.S. Food and Drug Administration regarding the iron drug Feraheme, according to a regulatory filing. ...More
September 21, 2010
Posted in News, Government & Regulation