← FDA DRUG APPROVALS

FDA BLA · BLA761090

TAKHZYRO

lanadelumab-flyo

Sponsor: DYAX CORP.

APPLICATION
BLA761090
TYPE
BLA
ORIGINAL APPROVAL
2018-08-23
LATEST ACTION
2023-02-03
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

TAKHZYROPrescription
LANADELUMAB-FLYO 300MG/2ML (150MG/ML) · SOLUTION · SUBCUTANEOUS
TAKHZYROPrescription
LANADELUMAB-FLYO 300MG/2ML (150MG/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2023-02-03Efficacy · Supplement 10 · priority — Letter ↗AP
2022-02-08Manufacturing (CMC) · Supplement 3 — Label ↗AP
2018-11-16Labeling · Supplement 1 · standard — Label ↗AP
2018-08-23Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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