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General MedicationsSUBCUTANEOUSStandard

INCRELEX

MECASERMIN RECOMBINANT

Standard Dose
40MG/4ML (10MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview INCRELEX is listed in Drugs@FDA under application 021839 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient MECASERMIN RECOMBINANT Form and strength INJECTABLE;SUBCUTANEOUS - 40MG/4ML (10MG/ML) Sponsor IPSEN INC Submission history Latest submission status date: 2025-07-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview INCRELEX is listed in Drugs@FDA under application 021839 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient MECASERMIN RECOMBINANT Form and strength INJECTABLE;SUBCUTANEOUS - 40MG/4ML (10MG/ML) Sponsor IPSEN INC Submission history Latest submission status date: 2025-07-09 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.