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defibrotide sodium

FDA Drug Profile — DEFITELIO

Drug Details

Generic Name
defibrotide sodium
Brand Names
DEFITELIO
Application Number
NDA208114
Sponsor
Jazz Pharmaceuticals, Inc.
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
DEFIBROTIDE SODIUM

Indications and Usage

1 INDICATIONS AND USAGE DEFITELIO is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). DEFITELIO is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). ( 1 )