The company is halting some pricing practices that critics say were contributing to overuse of its flagship anemia drug Aranesp at a time of mounting concerns about the product?s safety.
The company is halting some pricing practices that critics say were contributing to overuse of its flagship anemia drug Aranesp at a time of mounting concerns about the product?s safety.
The Food and Drug Administration approved Nplate for patients with a disorder that causes the body to attack its own platelets, tiny components of blood that help with clotting.
The Food and Drug Administration has ordered Amgen to change the labels for its flagship anemia drugs in a way that could further restrict their use in treating patients with cancer.
The move, which the F.D.A. is expected to announce on Wednesday, represents the first time the agency has ordered changes in a drug?s prescribing information.
Amgen reported a far better-than-expected quarterly profit as sales of its anemia drugs, hurt by safety concerns and reimbursement restrictions, declined less than expected, and the company raised its 2008 forecast.