Regulatory Decision Summary for Evapryde
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:
Summary of Cancellation: amisulpride (*EVAPRYDE)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The sponsor chose to cancel its submission before a final decision was issued.
Date of cancellation
January 21, 2021
What was the purpose of this submission?
This New Drug Submission (NDS) was filed to obtain market authorization for Evapryde (amisulpride) oral tablet for the treatment of acute and chronic schizophrenic disorders.
What did the company submit to support its submission?
This NDS was submitted through the Submission Relying on Third-Party Data (SRTD) regulatory pathway. The sponsor submitted quality, non-clinical, and clinical data packages, as well as labelling components.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
At the time of the cancellation, the review of the submission was ongoing. Health Canada had identified deficiencies in the package that would have precluded issuing an approval. Health Canada issued a Notice of Deficiency to the sponsor and the sponsor chose to withdraw their submission prior to sending a response.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There is no expected impact for patients using SAP or in clinical trials.
Additional information
*Proposed Brand Name:
Evapryde