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Omisirge
omidubicel-onlv
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Omisirge
Proper name
omidubicel-onlv
Licence type
351(a)
BLA number
125738
Applicant
Gamida Cell Ltd.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| >4.0x10^8 total viable cells, >2.4x10^7 CD3+ cells with 41mL dil sol; >8.0x10^8 total viable cells, >8.7% CD34+ cells, >9.2x10^7 CD34+ cells with 81mL dil so | For Injection | Intravenous | Bag | Rx | April 17, 2023 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | April 17, 2030 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |