FDA Panel OKs Use Of Anemia Drugs, Despite Study

Law360, New York (October 18, 2010, 7:03 PM EDT) -- A U.S. Food and Drug Administration panel said Monday that it was safe for kidney patients who do not require dialysis to continue use of erythropoiesis-stimulating agents made by Johnson & Johnson and Amgen Inc.

The Cardiovascular and Renal Drugs Advisory Committee voted 15-1 against ending use of the ESAs before dialysis and voted 9-5 against cutting doses to patients with hemoglobin levels below 9 grams per deciliter of blood, a representative for Amgen confirmed.

The vote followed a meeting that addressed a recent study finding...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.