The United States Pharmacopeia Accepts Amgen's Aranesp for Treatment of Chemotherapy-Associated Anemia
02.04.2002
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The USP promotes the public health by establishing and disseminating officially recognized standards of quality and authoritative information for the use of medicines and other health care technologies by health professionals, patients and consumers. USP expert committees routinely evaluate information on the use of drugs. The use of Aranesp(TM) for the treatment of chemotherapy-associated anemia and for anemia associated with chronic renal failure has been classified by the USP as "Accepted," or, supported by evidence and current medical practice. The USP will accept comments on the proposed monograph for the treatment of chemotherapy-associated anemia through March 4, 2002.
In the third quarter of 2001, Amgen submitted to the U.S. Food & Drug Administration (FDA) a Biologics License Application Supplement for Aranesp(TM) for the treatment of cancer patients suffering from anemia associated with certain types of chemotherapy. The company is awaiting FDA action. In September of 2001, the FDA approved Aranesp(TM) for the treatment of anemia associated with chronic renal failure including patients on and not on dialysis.
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