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FDA NDA · NDA215014

EMPAVELI

pegcetacoplan

Sponsor: APELLIS PHARMS

APPLICATION
NDA215014
TYPE
NDA
ORIGINAL APPROVAL
2021-05-14
LATEST ACTION
2025-07-28
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

EMPAVELI · ReferencePrescription
PEGCETACOPLAN 1080MG/20ML (54MG/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2025-07-28Efficacy · Supplement 11 · priority — Label ↗AP
2025-06-10Labeling · Supplement 10 · standard — Label ↗AP
2024-10-07REMS · Supplement 8 — Letter ↗AP
2024-02-08Labeling · Supplement 6 · standard — Label ↗AP
2023-09-28Labeling · Supplement 3 · standard — Label ↗AP
2023-02-08Efficacy · Supplement 2 · standard — Label ↗AP
2021-05-14Type 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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