Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling

FDA Drug Profile — Drax Exametazime

Drug Details

Generic Name
Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling
Brand Names
Drax Exametazime
Application Number
NDA208870
Sponsor
Jubilant DraxImage Inc., dba Jubilant Radiopharma
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
TECHNETIUM TC-99M EXAMETAZIME

Indications and Usage

1 INDICATIONS AND USAGE Drax Exametazime is indicated for leukocyte (white blood cell) labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease. Drax Exametazime is a radioactive diagnostic agent indicated for leukocyte (white blood cell) labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease. ( 1 )