Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2022

Month: August

Request Number: A-2021-001245

Request Summary: The Health Canada Generic Submissions Under Review List, an Abbreviated New Drug Submission (ANDS) for degarelix acetate was submitted on or after October 1, 2018. All records containing information regarding the evidence of clinical effectiveness of the new drug for the purpose and under the conditions of use recommended, as described in paragraph C.08.002(2)(h) of the Food and Drug Regulations.

Disposition: Disclosed in part

Number of pages: 23

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