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Avonex
interferon beta-1a
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Avonex
Proper name
interferon beta-1a
Licence type
351(a)
BLA number
103628
Applicant
Biogen Inc.
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 30MCG | For Injection | Intramuscular | Single-Dose Vial | Disc | May 17, 1996 |
| 30MCG/0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | May 28, 2003 |
| 30MCG/0.5ML | Injection | Intramuscular | Autoinjector | Rx | February 27, 2012 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | May 17, 2003 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |