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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA has approved Italfarmaco’s Duvyzat (givinostat) oral medication for treatment of Duchenne Muscular Dystrophy (DMD). Duvyzat is a non steroidal drug for treatment of DMD, a rare neurological disorder, characterised by progressive muscle weakness due to lack of muscle protein, dystrophin. Duvyzat is an oral suspension of givinostat 8.86mg/ml, administered twice daily and dosage is determined by patient’s body weight. Daily dosage for givinostat ranges from 22.2 to 53.2 mg given twice daily.
FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy
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