General MedicationsSUBCUTANEOUSStandard
ROLVEDON
EFLAPEGRASTIM-XNST
Standard Dose
13.2MG/0.6ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ROLVEDON is listed in Drugs@FDA under application 761148 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient EFLAPEGRASTIM-XNST Form and strength INJECTABLE;SUBCUTANEOUS - 13.2MG/0.6ML Sponsor SPECTRUM PHARMS Submission history Latest submission status date: 2025-12-12 00:00:00.
Structured Monograph
Clinical summary
Approval overview ROLVEDON is listed in Drugs@FDA under application 761148 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient EFLAPEGRASTIM-XNST Form and strength INJECTABLE;SUBCUTANEOUS - 13.2MG/0.6ML Sponsor SPECTRUM PHARMS Submission history Latest submission status date: 2025-12-12 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.