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Atryn
Antithrombin (Recombinant)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Atryn
Proper name
Antithrombin (Recombinant)
Licence type
351(a)
BLA number
125284
Applicant
rEVO Biologics, Inc.
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1750IU | For Injection | Intravenous | Single-Dose Vial | Disc | February 6, 2009 |
| 525IU | For Injection | Intravenous | Single-Dose Vial | Disc | April 11, 2014 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | February 6, 2016 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |