The biotechnology giant Amgen pleaded guilty Tuesday to illegally marketing its anemia drug Aranesp and agreed to pay $762 million in criminal penalties and settlements of whistle-blower lawsuits.

David Scott, Amgen's general counsel, entered the guilty plea at the U.S. District Court in Brooklyn to a single count of misbranding Aranesp, meaning selling it for uses not approved by the Food and Drug Administration.

The company agreed to pay $136 million in criminal fine and $14 million in a criminal forfeiture, as well as $612 million to settle various civil lawsuits from whistle-blowers.

The U.S. attorney's office for the Eastern District of New York said in court that Amgen had promoted uses of Aranesp at different frequencies and different doses than stated on the drug's label. This was apparently to try to increase use of the drug and to compete with a rival anemia drug from Johnson & Johnson.

Prosecutors also said that Amgen promoted Aranesp as a treatment for anemia in cancer patients who were not undergoing chemotherapy, even though the drug's approval was only for patients getting chemotherapy. The use of the drug in cancer patients not getting chemotherapy was later found to be dangerous.

The presiding judge, Sterling Johnson Jr., scheduled a hearing for Wednesday at which he said he would announce whether he had accepted the settlement. Until then, the whistle-blower lawsuits remain under seal.


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Marshall L. Miller, a federal prosecutor, called the agreement "a sweeping victory for the American public."

Aranesp, which is used to treat anemia caused by kidney disease or by cancer chemotherapy, was once Amgen's biggest seller. But sales have been declining because of concerns that the drug can cause heart attacks and make cancer worse.