EPO: FDA Approval for Chronic Renal Patients

• 1989 treatment of anemia associated with chronic renal failure

• 1994 supplement expanded target hematocrit (percentage of red blood cells in plasma), to a range of 30 to 36 percent from the previous target range of 30 to 33 percent

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EPO was approved in 1989. In that year, 14 significant new biological products were licensed by FDA's Center for Biologics Evaluation and Research. These 14 important new biological approvals were among 113 total biological approvals (licenses issued) for the year.