Regulatory Decision Summary for Exparel
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: bupivacaine (*EXPAREL)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company chose to cancel its submission before a final decision was issued.
Date of cancellation
August 5, 2021
What was the purpose of this submission?
This New Drug Submission (NDS) was filed to obtain market authorization for EXPAREL (bupivacaine extended-release liposome suspension) for use as: a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults.
What did the company submit to support its submission?
The sponsor submitted quality, clinical and non-clinical data packages, as well as labelling information.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
A Notice of Non-compliance (NON) was previously issued for this product on October 13, 2020. Health Canada was near completion of its review of the response to NON and in the process of Product Monograph editing when the sponsor cancelled their submission.
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:
Exparel