Active ingredient
Pegvaliase
3 finished FDA listings contain Pegvaliase as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PEGVALIASE
- Dosage forms
- Injection, Solution
- Routes
- Subcutaneous
- Manufacturers / labelers
- 1
- Strengths listed
- 10 mg/.5ml · 2.5 mg/.5ml · 20 mg/ml
- Brand names in FDA listings
- Palynziq
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2046360
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| BLA 761079 | BIOMARIN PHARM | 2018-05-24 | 3 |
Official labeling on DailyMed
- PALYNZIQ (PEGVALIASE-PQPZ) INJECTION, SOLUTION [BIOMARIN PHARMACEUTICAL INC.] · version 36 · 2026-03-09
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.