Renal Business Today - U.S. Food And Drug Administration (FDA)

FDA Approves APP’s Generic Hypertension, Fluid Retention Drug

SCHAUMBURG, Ill.— The U.S. Food and Drug Administration has approved APP Pharmaceutical’s Chlorothiazide Sodium for Injection, USP, which is used to treat high blood pressure , as well as fluid retention in people with congestive heart failure, cirrhosis of the liver, ...More

October 21, 2009

Posted in News, Business, Clinical & Pharma, Government & Regulation

Contaminated Heparin Syringes Emphasize Safety Protocols

An outbreak of bloodstream infections appears to have been caused by the contamination of pre-filled heparin and saline syringes made by a single company. The subsequent investigation revealed that the company was not in compliance with safety regulations and identified ...More

October 14, 2009

Posted in News, Business, Clinical & Pharma, Government & Regulation, Practice Management

FDA Approves Vaccine for 2009-2010 Seasonal Influenza

WASHINGTON—The U.S. Food and Drug Administration (FDA) has approved a vaccine for 2009-2010 seasonal influenza in the United States. ...More

July 21, 2009

Posted in News, Clinical & Pharma, Government & Regulation

FDA Requires Labeling Change for Some Transplant Drugs

The U.S. Food and Drug Administration (FDA) will require manufacturers of some immunosuppressant drugs used in kidney transplants to update their labeling to reflect an increased risk of infections. ...More

July 16, 2009

Posted in News, Clinical & Pharma, Government & Regulation

FDA Approves Nephros’ Dual Stage Ultrafilters

RIVER EDGE, N.J.—The U.S. Food and Drug Administration has given Nephros Inc. 501k approval to market its Dual Stage Ultrafilters (DSU) for in-line purification of dialysate water and bicarbonate solution. ...More

July 2, 2009

Posted in News, Business, Clinical & Pharma, Government & Regulation

FDA Approves AMAG’s Iron Drug Feraheme for CKD

LEXINGTON, Mass.—The U.S. Food and Drug Administration has approved AMAG Pharmaceuticals' Feraheme Injection for intravenous use as an iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. ...More

June 30, 2009

Posted in News, Business, Clinical & Pharma, Government & Regulation

Fresenius to Manufacture Saline in Mexico for U.S. Dialysis Market

WALTHAM, Mass.—The U.S. Food and Drug Administration has approved Fresenius Medical Care’s manufacturing facility in Mexico to make and distribute saline solution for dialysis treatment in the United States, the company announced June 19. ...More

June 19, 2009

Posted in News, Business, Clinical & Pharma, Government & Regulation

FDA Issues Advisory on Levemir Insulin

The U.S. Food and Drug Administration (FDA) issued a public health advisory after 129,000 vials of the long-acting insulin Levemir made by Novo Nordisk, Inc. were stolen and have reappeared and are being sold in the U.S. market. The stolen insulin vials may not have been ...More

June 16, 2009

Posted in News, Business, Clinical & Pharma, Government & Regulation

Genzyme Finds Virus at Manufacturing Facility

CAMBRIDGE, Mass.—Genzyme Corp. announced June 16 that it has found a virus that impairs cell growth in one of six bioreactors at its Allston Landing manufacturing facility. ...More

June 16, 2009

Posted in News, Business, Clinical & Pharma, Government & Regulation

FDA Issues Alert On Rapamune

The Wall Street Journal reported that the U.S. Food and Drug Administration (FDA) issued an alert June 11 about Wyeth’s kidney-transplant drug Rapamune saying "the safety and efficacy of this drug in liver or lung transplant patients have not been established." Rapamune is ...More

June 16, 2009

Posted in News, Clinical & Pharma, Government & Regulation

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