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General MedicationsSUBCUTANEOUSStandard

DAWNZERA (AUTOINJECTOR)

DONIDALORSEN SODIUM

Standard Dose
EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DAWNZERA (AUTOINJECTOR) is listed in Drugs@FDA under application 219407 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DONIDALORSEN SODIUM Form and strength SOLUTION;SUBCUTANEOUS - EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) Sponsor IONIS PHARMS INC Submission history Latest submission status date: 2025-08-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview DAWNZERA (AUTOINJECTOR) is listed in Drugs@FDA under application 219407 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DONIDALORSEN SODIUM Form and strength SOLUTION;SUBCUTANEOUS - EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) Sponsor IONIS PHARMS INC Submission history Latest submission status date: 2025-08-21 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.