← FDA DRUG APPROVALS

FDA BLA · BLA761148

ROLVEDON

eflapegrastim-xnst

Sponsor: SPECTRUM PHARMS

APPLICATION
BLA761148
TYPE
BLA
ORIGINAL APPROVAL
2022-09-09
LATEST ACTION
2025-12-12
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ROLVEDONPrescription
EFLAPEGRASTIM-XNST 13.2MG/0.6ML · INJECTABLE · SUBCUTANEOUS

Approval history

2025-12-12Labeling · Supplement 11 · standard — Letter ↗AP
2023-06-16Labeling · Supplement 2 · standard — Letter ↗AP
2022-09-09Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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