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FDA BLA · BLA125166

SOLIRIS

eculizumab

Sponsor: ALEXION PHARM

APPLICATION
BLA125166
TYPE
BLA
ORIGINAL APPROVAL
2007-03-16
LATEST ACTION
2026-06-30
ROUTE
INTRAVENOUS, IV (INFUSION)
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SOLIRISPrescription
ECULIZUMAB 300MG · INJECTABLE · IV (INFUSION)

Approval history

2026-06-30Labeling · Supplement 454 · standard — Letter ↗AP
2026-06-01REMS · Supplement 453 — Letter ↗AP
2025-06-27REMS · Supplement 450 — Letter ↗AP
2025-02-28Efficacy · Supplement 448 · priority — Label ↗AP
2024-09-19Labeling · Supplement 447 · standard — Label ↗AP
2024-06-28Labeling · Supplement 445 · standard — Label ↗AP
2024-03-22REMS · Supplement 443 — Letter ↗AP
2024-02-08Labeling · Supplement 446 · standard — Label ↗AP
2020-11-20Labeling · Supplement 434 · standard — Label ↗AP
2020-04-07REMS · Supplement 432 — Letter ↗AP
2019-06-27Efficacy · Supplement 431 · priority — Label ↗AP
2018-07-25Labeling · Supplement 427 · standard — Label ↗AP
2018-07-25REMS · Supplement 428 — Label ↗AP
2018-02-28Labeling · Supplement 426 · standard — Letter ↗AP
2017-10-23Efficacy · Supplement 422 · standard — Label ↗AP
2017-01-13Labeling · Supplement 417 · standard — Label ↗AP
2016-04-13REMS · Supplement 414 — Letter ↗AP
2015-12-03REMS · Supplement 413 — Letter ↗AP
2015-12-03Labeling · Supplement 412 · standard — Letter ↗AP
2014-10-10REMS · Supplement 409 — Letter ↗AP
2014-04-30Efficacy · Supplement 368 · standard — Letter ↗AP
2014-04-30Labeling · Supplement 380 · standard — Letter ↗AP
2012-12-21Labeling · Supplement 273 · standard — Letter ↗AP
2011-09-23Efficacy · Supplement 172 · priority — Review ↗AP
2010-06-04Labeling · Supplement 44 · standard — Letter ↗AP
2009-06-30Labeling · Supplement 33 · standard — Letter ↗AP
2007-03-16Type 1 - New Molecular Entity · Original · priority — Label ↗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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