← FDA DRUG APPROVALS

FDA BLA · BLA761173

STIMUFEND

pegflilgrastim-fpgk

Sponsor: FRESENIUS KABI USA

APPLICATION
BLA761173
TYPE
BLA
ORIGINAL APPROVAL
2022-09-01
LATEST ACTION
2025-10-21
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

STIMUFENDPrescription
PEGFILGRASTIM-FPGK 6MG/0.6ML · SOLUTION · INJECTION

Approval history

2025-10-21Labeling · Supplement 13 · standard — Label ↗AP
2025-03-26Labeling · Supplement 8 · standard — Label ↗AP
2023-09-29BIOSIMILAR · Supplement 2 · standard — Label ↗AP
2022-09-01UNKNOWN · 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →