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Krystexxa

Active substance: pegloticase

INJECTION, SOLUTION · PEGLOTICASE 8 mg/mL

United StatesActive

Marketing holder: Horizon Therapeutics USA, Inc.

Verified 2026-10-09 · openFDA NDC

Analogues in other countries
Composition
Analogues by country

Products with the same active substance registered in other countries.

CountryProducts
EU 1
  • Krystexxa
    pegloticase
    EMEA/H/C/002208
    Crealta Pharmaceuticals Ireland Limited
Import and control

Control by country

  • United Statesprescription only

    Source: openFDA NDC · record 01a1208c-3092-7be7-b03a-7f499b98acd9,01a12097-5aa9-79c6-83fe-cff174dfcaaa;count=2 · valid from 2026-10-09 · verified 2026-10-09

More on control status
Registration
Registration number
75987-080
Registration status
Active
Dispensing
Prescription only
Route
INTRAVENOUS
Sources
  • product · openFDA NDC · 75987-080 · Verified 2026-10-09 · open in source
  • registration_status · openFDA NDC · 75987-080 · Verified 2026-10-09 · open in source
  • ingredients.0 · openFDA NDC · 75987-080 · Verified 2026-10-09 · open in source