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Update on US Regulatory Review of Roxadustat in Anaemia of Chronic Kidney Disease americanpharmaceuticalreview
August 12, 2021
The US FDA has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients.

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