Amgen has recently been told by the FDA to reword the labeling of its flagship anemia drugs – Aranesp and Procrit – to further restrict their use in treating cancer patients.
The move, which the F.D.A. announced on Wednesday, represents the first time the agency has invoked authority under a 2007 law that empowered it to order changes in a drug’s prescribing information. Previously, the F.D.A. could only negotiate with a drug’s manufacturer to change the label.
Sales of the drugs, Aranesp and Procrit, have already plummeted in the last year because of studies suggesting that their use to treat the …read more