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FDA BLA · BLA208471

ADLYXIN

Sponsor: SANOFI-AVENTIS US

APPLICATION
BLA208471
TYPE
BLA
ORIGINAL APPROVAL
2016-07-27
LATEST ACTION
2026-03-12
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ADLYXINPrescription
LIXISENATIDE 0.15MG/3ML (0.05MG/ML) · SOLUTION · SUBCUTANEOUS
ADLYXINPrescription
LIXISENATIDE 0.3MG/3ML (0.1MG/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2026-03-12Labeling · Supplement 12 · standard — Letter ↗AP
2025-05-28Labeling · Supplement 10 · standard — Letter ↗AP
2024-11-01Labeling · Supplement 9 · standard — Label ↗AP
2023-09-28Labeling · Supplement 7 · standard — Label ↗AP
2022-06-10Labeling · Supplement 5 · 901 required — Letter ↗AP
2021-07-30Efficacy · Supplement 4 · standard — Letter ↗AP
2016-07-27Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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