Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2025

Month: February

Request Number: A-2023-001081

Request Summary: The initial cover letter indicating the brand name of the reference drug product and the dosage form of the generic drug in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2023-10-19 for the medicinal ingredient Liraglutide, and for any Abbreviated New Drug Submission (ANDS) with a Completed Review, containing the same medicinal ingredient. The Screening Acceptance Letter from Health Canada to the generic drug manufacturer confirming completion of screening of the ANDS for Liraglutide which appears in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2023-10-19, and for any ANDS with a Completed Review, containing the same medicinal ingredient. The conditions and the reference product used for the bioequivalence study of any and all generic drugs in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2023-10-19 for the medicinal ingredient Liraglutide, and for any ANDS with a Completed Review, containing the same medicinal ingredient. The comparative characterization studies to support active pharmaceutical ingredient (API) sameness of any and all generic drugs in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2023-10-19 for the medicinal ingredient Liraglutide, and for any ANDS with a Completed Review, containing the same medicinal ingredient. The Dosage Forms, Strengths, Composition, Packaging, and Package Sizes of any and all generic drugs in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2023-10-19 for the medicinal ingredient Liraglutide, and for any ANDS with a Completed Review, containing the same medicinal ingredient.

Disposition: Disclosed in part

Number of pages: 605

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