Regulatory Decision Summary for XIGDUO
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?
This Supplement to a New Drug Submission (SNDS) was filed to add the indications for use of Xigduo (dapagliflozin and metformin) in combination with a sulfonylurea and in combination with sitagliptin to the Xigduo Product Monograph, as recently approved for Forxiga (dapagliflozin).
Why was the decision issued?
The Xigduo Product Monograph was revised to add the indications of combination of Xigduo with a sulfonylurea and combination with sitagliptin, based on the studies reviewed as part of the previously filed SNDSs for use of Forxiga in combination with metformin and a sulfonylurea (SNDS control #180758), and in combination with metformin and sitagliptin (SNDS control #180845).
The Xigduo Product Monograph was revised based on cross-referencing to the currently approved Forxiga Product Monograph dated December 8, 2015.
The overall benefit-harm-uncertainty risk for Xigduo remains favourable.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.