omidubicel-onlv
Drug Details
- Generic Name
- omidubicel-onlv
- Brand Names
- OMISIRGE
- Application Number
- BLA125738
- Sponsor
- Gamida Cell Inc.
- NDC Codes
- 1
- Dosage Forms
- KIT
- Routes
- N/A
- Active Ingredients
- N/A
Indications and Usage
1 INDICATIONS AND USAGE OMISIRGE is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for the treatment of: adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infections. ( 1.1 ) adults and pediatric patients 6 years and older with severe aplastic anemia (SAA) following reduced intensity conditioning. ( 1.2 ) 1.1 Hematologic Malignancies OMISIRGE is indicated for the treatment of adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infections. 1.2 Severe Aplastic Anemia OMISIRGE is indicated for the treatment of adults and pediatric patients 6 years of age and older with severe aplastic anemia (SAA) following reduced intensity conditioning.