Regulatory Decision Summary for Apo-Fluticasone HFA
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?
This submission was filed for market authorisation of a generic alternative to the Canadian Reference Product (CRP), Flovent HFA. Apo-Fluticasone HFA is the first generic alternative to Flovent HFA to be authorized in Canada. This product is an inhalation aerosol (pressurized Metered Dose Inhaler or pMDI).
Why was the decision issued?
The product was shown to have the same ingredients in the same quantities, the equivalent physical and chemical properties and delivery device attributes as the CRP. Based on in vivo comparative pharmacokinetic study, combined with in vitro studies, the product was shown to be bioequivalent to the CRP. After evaluation of the submitted data package, Health Canada has granted authorization to the product.
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 |
|---|---|---|---|
| APO-FLUTICASONE HFA | 02510987 | APOTEX INC | FLUTICASONE PROPIONATE 250 MCG / ACT |