`(631) 924-4000 • (800) 645-1706 • Fax (631) 924-1731
`
`
`
`PRESS RELEASE
`
`
`
`
`FOR IMMEDIATE RELEASE
`June 17, 2005
`
`Contact:
`Contact Information:
`Walter Tozzi
`Director of Marketing
`American Regent, Inc.
`1-631-924-4000
`Venofer® (iron sucrose injection, USP) receives FDA approval for the
`Treatment of Iron Deficiency Anemia in Pre-Dialysis Patients
`
`Shirley, N.Y. - June 17, 2005: American Regent/Luitpold Pharmaceuticals announced today
`that the U.S. Food and Drug Administration (FDA) has approved Venofer® (iron sucrose
`injection, USP) for the treatment of iron deficiency anemia in Chronic Kidney Disease
`Patients Not on Dialysis.
`
`According to the National Kidney Foundation, 20 million Americans have Chronic Kidney
`Disease (CKD). Of these, approximately 8 million are considered to be Stages III and IV
`and many may require intravenous iron supplementation to treat iron deficiency anemia, a
`common complication of CKD. Patients with kidney failure suffer from a reduced ability to
`produce erythropoietin leading to impairment of new red blood cell production and
`eventually iron deficiency anemia. Iron is essential to effective hemoglobin and red blood
`cell production. Untreated depletion of iron stores leads to iron-deficient erythropoiesis and
`iron-deficiency anemia.
`
`First approved in 2000 for the treatment of iron deficiency anemia in patients undergoing
`hemodialysis on supplemental erythropoietin therapy, Venofer® received a positive
`national coverage decision by CMS in 2001 and has been assigned a specific HCPCS Code:
`J-1756 for that indication. Venofer®, currently the #1 prescribed IV iron, is the first and
`only non-dextran IV iron approved for use in the pre-dialysis population. Venofer® is now
`FDA approved at a higher dose of iron per single dose administration than any other IV
`iron.
`
`
`
`Pharmacosmos, Exh. 1058, p. 1
`
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`
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`In non-dialysis dependent CKD patients, Venofer® is administered to a total cumulative dose of
`1000mg over a 14 day period as a 200mg slow IV injection undiluted over 2 to 5 minutes on 5
`different occasions within the 14 day period. There is limited experience, however, with an
`infusion of 500mg, diluted in 250mL of 0.9% Sodium Chloride over 3.5 to 4 hours on days 1 &
`14; hypotension occurred in 2 of the 30 patients administered that dose in the clinical trial.
`
`To learn more about the use of Venofer® in CKD or to obtain a copy of the full prescribing
`information, please contact American Regent, Inc. at 800-645-1706.
`
`
`Venofer® is manufactured under license from Vifor (International) Inc., Switzerland
`
`
`View Full Prescribing Information
`
`
`Pharmacosmos, Exh. 1058, p. 2
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