Quick answers
- What is Pegvaliase-pqpz used for?
- The FDA-approved label (Palynziq, BioMarin Pharmaceutical Inc., March 2, 2026) says: “PALYNZIQ is indicated to reduce blood phenylalanine concentrations in adult and pediatric patients 12 years of age and older with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pegvaliase-pqpz have a boxed warning?
- Yes. The FDA label for Palynziq has a boxed warning (“WARNING: ANAPHYLAXIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Pegvaliase-pqpz?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pegvaliase-pqpz been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Pegvaliase-pqpz?
- 1 company lists prescription products of Pegvaliase-pqpz in the FDA NDC Directory, including BioMarin Pharmaceutical Inc..
What Pegvaliase-pqpz is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PALYNZIQ is indicated to reduce blood phenylalanine concentrations in adult and pediatric patients 12 years of age and older with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management. …
— FDA label: Palynziq, BioMarin Pharmaceutical Inc., effective March 2, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: ANAPHYLAXIS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Palynziq |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- BioMarin Pharmaceutical Inc.3 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761079 PALYNZIQ | Biomarin Pharm | May 24, 2018 | 7, latest February 27, 2026 2026: Efficacy · 2025: Labeling · 2023: REMS |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Palynziq, BioMarin Pharmaceutical Inc., effective March 2, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →