The candidate vaccine’s next steps will be going through the FDA’s Biologics License Application process.
|Articles|August 1, 2008
Anemia drugs to be restricted to fewer patients
Erythropoiesis stimulating agents will bear stricter labeling.
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Erythropoiesis stimulating agents (ESAs) will bear stricter labeling and will require the distribution of a Medication Guide, following new
- ESAs are not to be used in patients receiving chemotherapy when the expected outcome is cure.
- The anemia drugs shouldn't be given when hemoglobin levels are greater than or equal to 10 grams per deciliter.These changes were imposed by FDA under a 2007 law, which gave it the authority to order these changes, rather than negotiate with drug companies for them. This is the first time the agency has applied this law, necessitated by the fact that Amgen, maker of Aranesp and Epogen, did not agree with FDA on every revision. Amgen and Johnson & Johnson, maker of Procrit, said they would comply with these changes.
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