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FDA BLA · BLA761224

TEZSPIRE

tezepelumab-ekko

Sponsor: ASTRAZENECA AB

APPLICATION
BLA761224
TYPE
BLA
ORIGINAL APPROVAL
2021-12-17
LATEST ACTION
2025-10-17
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

TEZSPIREPrescription
TEZEPELUMAB-EKKO 210MG/1.91ML(110MG/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2025-10-17Efficacy · Supplement 6 · standard — Label ↗AP
2023-05-26Labeling · Supplement 3 · standard — Letter ↗AP
2023-02-01Efficacy · Supplement 1 · standard — Letter ↗AP
2021-12-17Type 1 - New Molecular Entity · Original · priority — 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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