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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Vamorolone is a synthetic corticosteroid approved by USFDA for the treatment of Duchenne Muscular Dystrophy (DMD). DMD is a rare inherited X-chromosome-linked disease manifested as progressive muscle degeneration and weakness, due to a lack of muscle protein called dystrophin. FDA granted orphan drug designation to Agamree. Santhera has also received positive review for Vamorolone in Europe and expect approval by late 2023.
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