Regulatory Decision Summary for Auro-Levocarb
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.
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What was the purpose of this submission?
This New Drug Submission (NDS) was filed to obtain market authorization, pursuant to section C.08.004 of the Food and Drugs Regulations, for Auro-Levocarb (levodopa and carbidopa) for the treatment of Parkinson’s disease, submitted by Auro Pharma Inc.
The current submission was filed as a comparative NDS using the generic product Apo-Levocarb, instead of an Abbreviated New Drug Submission because at the time of study conduct the strengths of the Canadian Reference Product (CRP), Sinemet, were either dormant (100 milligram [mg]/25 mg), “marketed” but under shortage (250 mg/25 mg) or cancelled post-market (100 mg/10 mg).
The demonstration of bioequivalence using Apo-Levocarb as the labeling standard is considered acceptable.
Why was the decision issued?
This New Drug Submission for Auro-Levocarb (levodopa and carbidopa) 100 mg/25 mg, 250 mg/25 mg and 100 mg/10 mg tablets by Auro Pharma Inc. has met the requirements of the Food and Drug Regulations insofar as the safety and efficacy (clinical) information is concerned, on the basis of the data submitted in support of bioequivalence.
Comparative in vivo bioequivalence studies of the proposed products versus the labeling standard products sourced from the Canadian market (Apo-Levocarb) were provided. The studies were conducted for two strengths (100 mg/25 mg and 250 mg/25 mg tablets), demonstrating bioequivalence between the proposed and labeling standard products. For the 100 mg/10mg tablet strength, a request for a waiver to perform comparative in vivo bioequivalence was provided.
The Quality requirements of Health Canada’s Bioequivalence of Proportional Formulations policy have been met.
Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.
The overall benefit-harm-uncertainty profile is favourable for Auro-Levocarb (levodopa and carbidopa) 100 mg/25 mg, 250 mg/25 mg and 100 mg/10 mg tablets for the recommended indication. A Notice of Compliance (NOC) was issued.
For further details about Auro-Levocarb, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Decision issued
Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| AURO-LEVOCARB | 02531607 | AURO PHARMA INC | CARBIDOPA 25 MG LEVODOPA 100 MG |
| AURO-LEVOCARB | 02531615 | AURO PHARMA INC | CARBIDOPA 25 MG LEVODOPA 250 MG |
| AURO-LEVOCARB | 02531593 | AURO PHARMA INC | CARBIDOPA 10 MG LEVODOPA 100 MG |