MedPath
FDA Approval

Arcalyst

May 8, 2023

HUMAN PRESCRIPTION DRUG LABEL

Rilonacept(160 mg in 2 mL)

Manufacturing Establishments (4)

Regeneron Pharmaceuticals, Inc.

Kiniksa Pharmaceuticals (UK), Ltd.

945589711

Kiniksa Pharmaceuticals (UK), Ltd.

Kiniksa Pharmaceuticals (UK), Ltd.

224568777

Jubilant HollisterStier LLC

Kiniksa Pharmaceuticals (UK), Ltd.

069263643

Packing Coordinators LLC

Kiniksa Pharmaceuticals (UK), Ltd.

078525133

Products (1)

Arcalyst

73604-914

BLA125249

BLA (C73585)

SUBCUTANEOUS

May 8, 2023

Code: 8K80YB5GMGClass: ACTIBQuantity: 160 mg in 2 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
ARGININEInactive
Code: 94ZLA3W45FClass: IACT
GLYCINEInactive
Code: TE7660XO1CClass: IACT
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