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Besremi
ropeginterferon alfa-2b-njft
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Besremi
Proper name
ropeginterferon alfa-2b-njft
Licence type
351(a)
BLA number
761166
Applicant
PharmaEssentia Corporation
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 500MCG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | June 25, 2026 |
| 500MCG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | November 12, 2021 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | November 12, 2028 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |