← FDA DRUG APPROVALS

FDA BLA · BLA761111

NYVEPRIA

pegfilgrastim-apgf

Sponsor: HOSPIRA INC

APPLICATION
BLA761111
TYPE
BLA
ORIGINAL APPROVAL
2020-06-10
LATEST ACTION
2026-05-21
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

NYVEPRIAPrescription
PEGFILGRASTIM-APGF 6MG/0.6ML · INJECTABLE · INJECTION

Approval history

2026-05-21Labeling · Supplement 10 · standard — Label ↗AP
2021-04-16Labeling · Supplement 4 · standard — Label ↗AP
2020-06-10Type 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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