Purple Book product · Reference 351(a)
kresladi
marnetegragene autotemcel
Mar 26, 2026
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Mar 26, 2026
4 mo ago
Today
Pharmaceutical detail
Strength
0.34 to 6.1 × 10^6 cells/mL (including 0.32 to 6.1 × 10^6 CD34+ cells/mL)
Dosage form
Suspension
Route
Intravenous
Presentation
Bag
Center
CBER
License number
2328
Product number
001
Submission type
Original
Supplement number
0
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does kresladi have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing kresladi are listed in the FDA Purple Book yet.
What is kresladi's BLA number?
kresladi is licensed under BLA 125806, held by Rocket Pharmaceuticals Inc.
When was kresladi approved by the FDA?
kresladi was approved by the FDA on Mar 26, 2026.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
