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General MedicationsINTRATHECALStandard

QALSODY

TOFERSEN

Standard Dose
100MG/15ML (6.7MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview QALSODY is listed in Drugs@FDA under application 215887 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient TOFERSEN Form and strength SOLUTION;INTRATHECAL - 100MG/15ML (6.7MG/ML) Sponsor BIOGEN MA Submission history Latest submission status date: 2023-04-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview QALSODY is listed in Drugs@FDA under application 215887 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient TOFERSEN Form and strength SOLUTION;INTRATHECAL - 100MG/15ML (6.7MG/ML) Sponsor BIOGEN MA Submission history Latest submission status date: 2023-04-25 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.