← FDA DRUG APPROVALS

FDA BLA · BLA761084

FYLNETRA

pegfilgrastim

Sponsor: KASHIV BIOSCIENCES LLC

APPLICATION
BLA761084
TYPE
BLA
ORIGINAL APPROVAL
2022-05-26
LATEST ACTION
2025-04-23
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

FYLNETRAPrescription
PEGFILGRASTIM-PBBK 6MG/0.6ML · INJECTABLE · INJECTION

Approval history

2025-04-23BIOSIMILAR · Supplement 7 · standard — Label ↗AP
2022-05-26Type 2 - New Active Ingredient · Original · standard — Label ↗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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