← FDA DRUG APPROVALS

FDA BLA · BLA761079

PALYNZIQ

pegvaliase-pqpz

Sponsor: BIOMARIN PHARM

APPLICATION
BLA761079
TYPE
BLA
ORIGINAL APPROVAL
2018-05-24
LATEST ACTION
2026-02-27
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PALYNZIQPrescription
PEGVALIASE-PQPZ 20MG/ML · INJECTABLE · INJECTION
PALYNZIQPrescription
PEGVALIASE-PQPZ 2.5MG/0.5ML · INJECTABLE · INJECTION
PALYNZIQPrescription
PEGVALIASE-PQPZ 10MG/0.5ML · INJECTABLE · INJECTION

Approval history

2026-02-27Efficacy · Supplement 31 · priority — Letter ↗AP
2025-11-20Labeling · Supplement 34 · standard — Label ↗AP
2023-12-09REMS · Supplement 25 — Letter ↗AP
2020-11-20Labeling · Supplement 10 · standard — Label ↗AP
2020-10-06Efficacy · Supplement 6 · standard — Letter ↗AP
2020-10-06Efficacy · Supplement 7 · standard — Letter ↗AP
2020-10-06Efficacy · Supplement 5 · standard — Letter ↗AP
2018-05-24Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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