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FDA Approves Extended Dosing of Aranesp

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Amgen has received approval from the FDA for extended, every-three-week, dosing of Aranesp for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies. Aranesp is the only erythropoiesis-stimulating agent approved by the FDA for every-three-week administration.

The update to the Aranesp label now includes a recommended starting dose of 500 mcg once every three weeks in addition to the recommended starting dose of 2.25 mcg/kg once weekly. The new dosing recommendations are based on a randomized, double-blind, Phase III study that evaluated the safety and effectiveness of every-three-week administration of Aranesp.

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