Regulatory Decision Summary for PMS-Fluoxetine
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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Type of submission:
Control number:
What was the purpose of this submission?
The sponsor submitted a New Drug Submission (NDS) to obtain marketing approval of PMS-Fluoxetine (fluoxetine hydrochloride) (40 mg, 60 mg capsules), indicated for the treatment of:
Depression: PMS-Fluoxetine is indicated for the symptomatic relief of Major Depressive Disorder (MDD).
Bulimia Nervosa: PMS-Fluoxetine has been shown to significantly decrease binge-eating and purging activity when compared with placebo treatment.
Obsessive-Compulsive Disorder: PMS-Fluoxetine is indicated for the symptomatic treatment of obsessive-compulsive disorder (OCD).The obsessions or compulsions must be experienced as intrusive, markedly distressing, time consuming, or interfering significantly with the persons social or occupational functioning.
The initial Abbreviated New Drug Submission for PMS-Fluoxetine capsules (10 and 20 mg), using Prozac as the Canadian Reference Product (CRP), was cleared in 1999 (Control #054036). This line extension was initially filed as a Supplementary Abbreviated New Drug Submission in May 2016 (#195402) but was withdrawn during screening due to having no CRP for these strengths and, therefore, not acceptable as a generic filing. The proposed strengths (40 and 60 mg) do not have a direct CRP, so they were compared to multiple doses of the 10 and 20 mg Prozac strengths. These higher strengths are acceptable as they do still fall within the approved dosing range for the product.
Why was the decision issued?
This submission is for the market authorization of generic fluoxetine capsules. The sponsor has already marketed two other capsule strengths (10 mg and 20mg). They are adding the 40 mg and 60 mg strengths. The capsules could not be authorized under the traditional generic regulatory stream as the innovator does not have these two capsule strengths approved. However, 40 mg and 60 mg are within the recommended dosing regimen for fluoxetine. Therefore, the generic sponsor filed these two capsule strengths as a NDS. The approval was based on the chemistry and bioequivalence of the two capsules to multiple capsules of the lower strength by the innovator. The benefit-harm-uncertainty profile is acceptable as it is equivalent to the innovator product, 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 |
|---|---|---|---|
| PMS-FLUOXETINE | 02464640 | PHARMASCIENCE INC | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) 40 MG |
| PMS-FLUOXETINE | 02464659 | PHARMASCIENCE INC | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) 60 MG |