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General MedicationsINJECTIONStandard

FYLNETRA

PEGFILGRASTIM-PBBK

Standard Dose
6MG/0.6ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview FYLNETRA is listed in Drugs@FDA under application 761084 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient PEGFILGRASTIM-PBBK Form and strength INJECTABLE;INJECTION - 6MG/0.6ML Sponsor KASHIV BIOSCIENCES LLC Submission history Latest submission status date: 2025-04-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview FYLNETRA is listed in Drugs@FDA under application 761084 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient PEGFILGRASTIM-PBBK Form and strength INJECTABLE;INJECTION - 6MG/0.6ML Sponsor KASHIV BIOSCIENCES LLC Submission history Latest submission status date: 2025-04-23 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.