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General MedicationsINJECTIONStandard

COLUMVI

GLOFITAMAB-GXBM

Standard Dose
10MG/10ML(1MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview COLUMVI is listed in Drugs@FDA under application 761309 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient GLOFITAMAB-GXBM Form and strength INJECTABLE;INJECTION - 10MG/10ML(1MG/ML) Sponsor GENENTECH INC Submission history Latest submission status date: 2025-10-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview COLUMVI is listed in Drugs@FDA under application 761309 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient GLOFITAMAB-GXBM Form and strength INJECTABLE;INJECTION - 10MG/10ML(1MG/ML) Sponsor GENENTECH INC Submission history Latest submission status date: 2025-10-27 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.