Regulatory Decision Summary for Restasis Multidose
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.
Type of submission:
What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) was to seek approval of a new product, Restasis MultiDoseTM (Cyclosporine Ophthalmic Emulsion 0.05%) formulation, which is the same product as the currently approved and marketed non-preserved product Restasis.
Why was the decision issued?
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.