Home PurpleBook 125738 OMISIRGE Purple Book BLA 125738
BLA number 125738
Proprietary names OMISIRGE
Proper names omidubicel-onlv
Applicant Gamida Cell Ltd.
Center CBER
First observed release 2023-04-01
Latest observed release 2026-06-01
Newest archive release 2026-06-01
FDA patent list No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage Present in newest release Latest Known Product Presentations# Product, Proprietary name, Proper name table Product Proprietary name Proper name License type Strength Dosage form Route Presentation Marketing Licensure Approval Patent list provided 001 OMISIRGE omidubicel-onlv 351(a) >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 Licensed 2023-04-17 002 OMISIRGE omidubicel-onlv 351(a) >8.0x10^8 total viable cells, >8.7% CD34+ cells, >9.2x10^7 CD34+ cells with 81mL dil so For Injection Intravenous Bag Rx Licensed 2023-04-17
Published Patent List# No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events# Release, Event, Product table Release Event Product Name License type Status Applicant 2025-03-01 U 001 OMISIRGE 351(a) Rx Gamida Cell Ltd. 2023-05-01 U 001 OMISIRGE 351(a) Rx Gamida Cell Ltd. 2023-05-01 U 002 OMISIRGE 351(a) Rx Gamida Cell Ltd. 2023-04-01 N 001 OMISIRGE 351(a) Rx Gamida Cell Ltd. 2023-04-01 N 002 OMISIRGE 351(a) Rx Gamida Cell Ltd.
Observed Product State History# Release, Product, Name table Release Product Name License type Marketing Licensure Approval 2023-04-01 001 OMISIRGE 351(a) Rx Licensed 2023-04-17 2023-04-01 002 OMISIRGE 351(a) Rx Licensed 2023-04-17
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