Regulatory Decision Summary for AA-clozapine
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.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
The purpose of this New Drug Submission was to seek marketing authorization for two new strengths (50 mg and 200 mg) for AA-Clozapine tablets. Also, during the review period the submission underwent an administrative change to the sponsor from Apotex Incorporated to AA-Pharma Inc., therefore the brand name changed from APO-Clozapine" to "AA-Clozapine".
Why was the decision issued?
The submission was for new tablet strengths, however, the new tablets are within the approved dosing range for clozapine. Therefore, there is no change to the Benefit-Harm-Uncertainty profile of the drug, and a Notice of Compliance was issued.
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 |
|---|---|---|---|
| AA-CLOZAPINE | 02458748 | AA PHARMA INC | CLOZAPINE 50 MG |
| AA-CLOZAPINE | 02458756 | AA PHARMA INC | CLOZAPINE 200 MG |