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Palynziq
pegvaliase-pqpz
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Palynziq
Proper name
pegvaliase-pqpz
Licence type
351(a)
BLA number
761079
Applicant
BioMarin Pharmaceutical Inc.
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | May 24, 2018 |
| 2.5MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | May 24, 2018 |
| 20MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | May 24, 2018 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | May 24, 2025 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |