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General MedicationsINTRAVENOUSStandard

AMONDYS 45

CASIMERSEN

Standard Dose
100MG/2ML (50MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview AMONDYS 45 is listed in Drugs@FDA under application 213026 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CASIMERSEN Form and strength SOLUTION;INTRAVENOUS - 100MG/2ML (50MG/ML) Sponsor SAREPTA THERAPS INC Submission history Latest submission status date: 2026-01-06 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMONDYS 45 is listed in Drugs@FDA under application 213026 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CASIMERSEN Form and strength SOLUTION;INTRAVENOUS - 100MG/2ML (50MG/ML) Sponsor SAREPTA THERAPS INC Submission history Latest submission status date: 2026-01-06 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.