infliximab-dyyb

FDA Drug Profile — INFLECTRA, ZYMFENTRA

Drug Details

Generic Name
infliximab-dyyb
Brand Names
INFLECTRA, ZYMFENTRA
Application Number
BLA125544
Sponsor
Pfizer Laboratories Div Pfizer Inc
NDC Codes
7
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, INJECTION, INJECTION, SOLUTION, KIT
Routes
INTRAVENOUS, SUBCUTANEOUS
Active Ingredients
INFLIXIMAB, INFLIXIMAB-DYYB

Indications and Usage

1 INDICATIONS AND USAGE ZYMFENTRA is a tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. ( 1 ) moderately to severely active Crohn’s disease following with an infliximab products administered intraneously. ( 1 ) ZYMFENTRA is indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. moderately to severely active Crohn's disease following treatment with an infliximab product administered intravetnously.