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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
FDA approved Akebia’s Vafseo (Vadadustat) for treatment of anaemia due to Chronic Kidney Disease (CKD) in patients receiving dialysis for at least three months. Vafseo is a once daily oral tablet and recommended starting dose 300 mg. Vafseo is available as 150 mg, 300 mg, and 450 mg tablets
Earlier in April 2023 Vafseo (vadadustat) was authorised in Europe for treating anaemia in patients with chronic kidney disease. The drug is also approved in Japan in 2020 for treatment of anemia due to Chronic Kidney Disease in dialysis-dependent and non-dialysis dependent adult patients. The USFDA approval for Vafseo comes after initial rejection by FDA in 2022 for concerns of potential liver injury.
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