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General MedicationsSUBCUTANEOUSStandard

KESIMPTA

OFATUMUMAB

Standard Dose
20MG/0.4ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview KESIMPTA is listed in Drugs@FDA under application 125326 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient OFATUMUMAB Form and strength SOLUTION;SUBCUTANEOUS - 20MG/0.4ML Sponsor NOVARTIS Submission history Latest submission status date: 2026-04-01 00:00:00.

Structured Monograph

Clinical summary

Approval overview KESIMPTA is listed in Drugs@FDA under application 125326 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient OFATUMUMAB Form and strength SOLUTION;SUBCUTANEOUS - 20MG/0.4ML Sponsor NOVARTIS Submission history Latest submission status date: 2026-04-01 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.