Regulatory Decision Summary for DEXEDRINE TABLETS, DEXEDRINE SPANSULES
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:
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What was the purpose of this submission?
Dexedrine and Dexedrine Spansules are pharmaceutical products approved under Division 1 of the Food and Drug Regulations for the adjunctive treatment of narcolepsy and for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This submission has been filed as per Health Canada’s re-classification of dextroamphetamine sulfate from Division 1 to Division 8 under the Food and Drug Regulations.
Why was the decision issued?
The Benefit-Harm-Uncertainties (BHU) profile of Dexedrine was already established at the moment of submission.
The filing of this New Drug Submission (NDS) was solicited by the Therapeutic Products Directorate’s (TPD) proposal for re-classification of dextroamphetamine sulfate from Division 1 to Division 8 under the Food and Drug Regulations. The reason for this NDS was to align the Product Monograph (PM) of Dexedrine with the PMs of all other stimulants of the amphetamine drug class marketed in Canada, which are all regulated under Division 8 of the Food and Drug Regulations.
No efficacy assessment was performed for this NDS.
The safety profile of Dexedrine was assessed through Periodic Safety Update Reports of marketing experience in Canada covering the period 2009-2015. The PMs of amphetamines marketed by other sponsors as well as the United States Package Insert (USPI) for Dexedrine were also used to update Dexedrine’s PM. Most sections were updated and some were completely modified as the information provided was fairly outdated.
Considering all the changes made in the final agreed upon PM (17 March 2016), the BHU profile of Dexedrine is now considered improved when Dexedrine is used under the conditions described in the PM.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| DEXEDRINE SPANSULE | 01924559 | ENDO OPERATIONS LTD. | DEXTROAMPHETAMINE SULFATE 10 MG |
| DEXEDRINE SPANSULE | 01924567 | ENDO OPERATIONS LTD. | DEXTROAMPHETAMINE SULFATE 15 MG |
| DEXEDRINE | 01924516 | ENDO OPERATIONS LTD. | DEXTROAMPHETAMINE SULFATE 5 MG |