← FDA DRUG APPROVALS

FDA BLA · BLA761164

ENJAYMO

sutimlimab-jome

Sponsor: RECORDATI RARE DISEASES, INC.

APPLICATION
BLA761164
TYPE
BLA
ORIGINAL APPROVAL
2022-02-04
LATEST ACTION
2024-02-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ENJAYMOPrescription
SUTIMLIMAB-JOME 1,100MG/22ML(50MG/ML) · INJECTABLE · INJECTION

Approval history

2024-02-08Labeling · Supplement 4 · standard — Label ↗AP
2023-01-25Efficacy · Supplement 3 · priority — Letter ↗AP
2022-09-23Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2022-02-04Type 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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