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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  08/13/2004
Trade Name:  Ferrlecit
Generic Name or Proper Name (*):  sodium ferric gluconate complex
Indications Studied:  Iron deficiency anemia in chronic hemodialysis patients receiving supplemental erythropoietin therapy
Label Changes Summary:  * Safety and effectiveness established in pediatric patients 6 -15 years old * Patients <6 years of age not studied * Information on dose, PK parameters and AE profile
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Watson
Pediatric Exclusivity Granted Date:  03/24/2004
Therapeutic Category:  Vitamin