Regulatory Decision Summary for Drax Exametazime
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
After evaluation of the submitted data package, Health Canada authorized the Schedule C drug Drax Exametazime (kit for the preparation of technetium [Tc 99m] exametazime for leukocyte labelling) for the following indication:
Tc 99m Exametazime is an effective agent for in vitro Tc 99m leukocyte radiolabelling. Tc 99m labelled leukocytes are useful in the detection of sites of focal infection, especially abdominal abscess and as an adjunct in the investigation of pyrexia of unknown origin (PUO), and in the evaluation of inflammatory conditions not associated with infection such as inflammatory bowel disease (IBD).
Why was the decision issued?
Drax Exametazime is considered pharmaceutically equivalent to that of the Canadian Reference Product (CRP), Ceretec, by GE Healthcare Canada Inc. (Mississauga, Ontario). The above indication has been authorized for Ceretec.
Authorization of Drax Exametazime was based on comparability between Drax Exametazime and the CRP (Ceretec) in terms of quality attributes. The sponsor conducted studies to compare the physicochemical properties of Drax Exametazime and Ceretec. No new animal or clinical studies were submitted for this abbreviated new drug submission (ANDS). However, the sponsor provided an acceptable rationale and a biowaiver request, which was deemed commensurate with the overall ANDS process.
Based on an assessment of the information provided in the submission, Drax Exametazime (kit for the preparation of technetium (Tc 99m) exametazime for leukocyte labelling) is considered having an acceptable benefit/risk profile for the claimed indication.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| DRAX EXAMETAZIME | 02495848 | JUBILANT DRAXIMAGE INC. DBA JUBILANT RADIOPHARMA | EXAMETAZIME 0.5 MG / VIAL |