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Ruconest
C1 Esterase Inhibitor (Recombinant)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Ruconest
Proper name
C1 Esterase Inhibitor (Recombinant)
Licence type
351(a)
BLA number
125495
Applicant
Pharming Americas BV
Center
CBER
Presentations
1
First licensure
July 16, 2014
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 2100IU | For Injection | Intravenous | Single-Dose Vial | Rx | July 16, 2014 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | July 16, 2021 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |