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Imlygic
Talimogene laherparepvec
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Imlygic
Proper name
Talimogene laherparepvec
Licence type
351(a)
BLA number
125518
Applicant
Amgen Inc.
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1 MILLION PFU/ML | For Injection | Intralesional | Single-Dose Vial | Rx | October 27, 2015 |
| 100 MILLION PFU/ML | For Injection | Intralesional | Single-Dose Vial | Rx | October 27, 2015 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | October 27, 2022 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |