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General MedicationsSINGLE-USEStandard

ARCALYST

RILONACEPT

Standard Dose
220MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ARCALYST is listed in Drugs@FDA under application 125249 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient RILONACEPT Form and strength VIAL; SINGLE-USE - 220MG Sponsor KINIKSA PHARMACEUTICALS (UK), LTD.

Structured Monograph

Clinical summary

Approval overview ARCALYST is listed in Drugs@FDA under application 125249 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient RILONACEPT Form and strength VIAL; SINGLE-USE - 220MG Sponsor KINIKSA PHARMACEUTICALS (UK), LTD. Submission history Latest submission status date: 2026-03-10 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.