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General MedicationsORALStandard

AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)

AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE

Standard Dose
EQ 0.8MG BASE;EQ 200MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) is listed in Drugs@FDA under application 219616 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE Form and strength CAPSULE, TABLET;ORAL - EQ 0.8MG BASE;EQ 200MG BASE Sponsor VERASTEM INC Submission history Latest submission status date: 2025-05-08 00:00:00.

Structured Monograph

Clinical summary

Approval overview AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) is listed in Drugs@FDA under application 219616 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE Form and strength CAPSULE, TABLET;ORAL - EQ 0.8MG BASE;EQ 200MG BASE Sponsor VERASTEM INC Submission history Latest submission status date: 2025-05-08 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) (AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE) | Drug Monograph | MedicHelpline