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These highlights do not include all the information needed to use LOARGYS safely and effectively. See full prescribing information for LOARGYS. LOARGYS (pegzilarginase-nbln) injection, for intravenous or subcutaneous use Initial U.S. Approval: 2026
Medication labelWhy this: Advisory · dailymed-prescription
LOARGYS is indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction. This indication is approved under accelerated approval based on reduction of plasma arginine [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- generic_name
- pegzilarginase-nbln
- product_names
- pegzilarginase-nbln
- ndc
- 81583-102, 81583-102-01, 81583-105, 81583-105-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en