Regulatory Decision Summary for Mar-Acarbose
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?
This Abbreviated New Drug Submission (ANDS) was filed by Marcan Pharmaceuticals Incorporated to obtain market authorization for a generic form of acarbose oral immediate-release tablets containing either 50 mg or 100 mg.
Acarbose is an oral anti-diabetic agent indicated as both monotherapy and in combination with other agents. The Canadian Reference Product (CRP) is Glucobay (50 mg and 100 mg acarbose tablets), marketed by Bayer Incorporated.
The submitted application does not contain in vivo comparative bioavailability data comparing the proposed product to the CRP. A Biopharmaceutics Classification System (BCS)-based biowaiver is requested. The data and information requirements for a BCS-based biowaiver are outlined in the Health Canada Guidance Document: Biopharmaceutics Classification System (BCS)-based Biowaiver (2014).
Why was the decision issued?
Acarbose is a drug substance that acts locally in the gastrointestinal tract to inhibit α-glucosidase activity in the brush border membrane of the small intestine. The Health Canada Guidance Document: Biopharmaceutics Classification System Based Biowaiver (2014) states the following: "The scope of this document is limited to immediate-release, solid oral pharmaceutical drug products regulated under the Food and Drug Act that are intended to deliver medication to the systemic circulation and does not apply to products subject to buccal or sublingual absorption." Therefore, a locally acting drug such as acarbose is not eligible for a BCS-based biowaiver.
Since acarbose exhibits low systemic bioavailability, an evaluation of bioequivalence based on comparative bioavailability is not feasible but, alternate methods of comparison can be employed including comparisons derived from the underlying scientific principles for the above-noted guidance document.
Based on method of action and characteristics of the drug substance, the similarity of the proposed drug product formulation to the CRP, and the similarity of the dissolution characteristics of the proposed product and the CRP, a waiver from the requirement for in vivo bioequivalence data was granted.
Mar-Acarbose (50 mg and 100 mg acarbose tablets) has the identical medicinal ingredient, dosage form, route of administration and conditions of use as those of the CRP.
The drug substance and drug product are manufactured in a consistent manner.
Marcan Pharmaceuticals Incorporated was granted authorization to market the generic 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 |
|---|---|---|---|
| MAR-ACARBOSE | 02494078 | MARCAN PHARMACEUTICALS INC | ACARBOSE 50 MG |
| MAR-ACARBOSE | 02494086 | MARCAN PHARMACEUTICALS INC | ACARBOSE 100 MG |