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General MedicationsSUBCUTANEOUSGeneric

KYNAMRO

MIPOMERSEN SODIUM

Standard Dose
200MG/ML (200MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: 901 REQUIRED Marketing status: Discontinued
Summary

Approval overview KYNAMRO is listed in Drugs@FDA under application 203568 (NDA).

Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient MIPOMERSEN SODIUM Form and strength SOLUTION;SUBCUTANEOUS - 200MG/ML (200MG/ML) Sponsor KASTLE THERAPS LLC Submission history Latest submission status date: 2019-03-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview KYNAMRO is listed in Drugs@FDA under application 203568 (NDA). Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient MIPOMERSEN SODIUM Form and strength SOLUTION;SUBCUTANEOUS - 200MG/ML (200MG/ML) Sponsor KASTLE THERAPS LLC Submission history Latest submission status date: 2019-03-18 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: 901 REQUIRED

Interaction Notes

  • No interaction notes stored yet.