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General MedicationsINTRAVENOUSStandard

LIBTAYO

CEMIPLIMAB-RWLC

Standard Dose
350MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview LIBTAYO is listed in Drugs@FDA under application 761097 (BLA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient CEMIPLIMAB-RWLC Form and strength INJECTABLE;INTRAVENOUS - 350MG Sponsor REGENERON PHARMACEUTICALS Submission history Latest submission status date: 2025-10-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview LIBTAYO is listed in Drugs@FDA under application 761097 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient CEMIPLIMAB-RWLC Form and strength INJECTABLE;INTRAVENOUS - 350MG Sponsor REGENERON PHARMACEUTICALS Submission history Latest submission status date: 2025-10-29 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.