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FDA Makes Changes in Erythropoietin Labeling

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

By Kevin E. Noonan -- The Food and Drug Administration posted a notice on its website today that further restricts prescription of two erythropoietin drugs (Amgen's Epogen®/Aransesp® and Johnson & Johnson's Procrit®) to cancer patients. The notice is part of the FDA's ongoing safety review of these drugs, and is a "follow-up" to a January 3, 2008 Official Communication. In the notice, the FDA announced that it will require what it terms "safety-related" changes in how these drugs are labeled. The changes include replacing the Package Insert with a Medication Guide, modifying particular sections of "the Boxed Warnings, Indications and...

Full post as published by Patent Docs on July 31, 2008 (boomark / email).