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FDA BLA · BLA761122

NUCALA

mepolizumab

Sponsor: GLAXOSMITHKLINE

APPLICATION
BLA761122
TYPE
BLA
ORIGINAL APPROVAL
2019-06-06
LATEST ACTION
2025-08-06
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

NUCALAPrescription
MEPOLIZUMAB 100MG/ML · INJECTABLE · SUBCUTANEOUS

Approval history

2025-08-06Labeling · Supplement 22 · standard — Letter ↗AP
2023-03-08Labeling · Supplement 11 · standard — Label ↗AP
2022-01-22Manufacturing (CMC) · Supplement 8 — Letter ↗AP
2021-07-29Efficacy · Supplement 6 · standard — Letter ↗AP
2020-09-25Labeling · Supplement 5 · standard — Label ↗AP
2019-09-12Efficacy · Supplement 3 · standard — Letter ↗AP
2019-09-12Labeling · Supplement 2 · standard — Letter ↗AP
2019-06-06Type 3 - New Dosage Form · 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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