J&J Procrit Label Adds Warning On Treatment To High Hemoglobin Levels
This article was originally published in The Pink Sheet Daily
Executive Summary
The labeling change stems from a clinical trial of another erythropoietin product where increased mortality was observed in patients treated to high hemoglobin target levels. Amgen has included the information from the study in its label for Epogen.
You may also be interested in...
Aranesp Joins Other EPO Products With Hemoglobin Treatment Goal Warning
J&J's Procrit and Amgen's Epogen previously added similar labeling language cautioning physicians not to treat patients to hemoglobin levels above 12 grams per deciliter. The warnings are based on ex-U.S. studies of J&J's Eprex and Roche's NeoRecormon.
Barr’s Expanded Thalidomide ANDA Could Increase Likelihood Of A Marketed Generic
Amended application includes 50 mg and 100 mg dosage forms, which are used in multiple myeloma.