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Aimovig
erenumab-aooe
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Aimovig
Proper name
erenumab-aooe
Licence type
351(a)
BLA number
761077
Applicant
Amgen Inc.
Center
CDER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 140MG/ML | Injection | Subcutaneous | Autoinjector | Rx | March 11, 2019 |
| 140MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | March 11, 2019 |
| 70MG/ML | Injection | Subcutaneous | Autoinjector | Rx | May 17, 2018 |
| 70MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Disc | May 17, 2018 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |