Regulatory Decision Summary for Zeulide Depot

This submission was filed in response to the Notice of Deficiency issued on August 16, 2022. In the response, the sponsor withdrew the five indications originally proposed in the Supplement to a New Drug Submission. The only remaining approved indication is for the treatment of prostate cancer, which had been previously authorized.

The submission also included updates to the Product Monograph. Specifically, the administration instructions for Zeulide Depot 3.75 mg and 22.5 mg were revised following identification of handling errors by the European Medicines Agency, which could potentially result in lack of efficacy. Additionally, intracranial idiopathic hypertension was added to the Warnings and Precautions section.

No new indication was proposed in this submission.

Additional safety information regarding intracranial idiopathic hypertension was proposed for inclusion in the Warnings and Precautions section of the Product Monograph. This update was based on the Periodic Safety Update Report review conducted by the European Medicines Agency.

Updates to the Instructions for Use were also made to emphasize that the instructions for reconstitution and administration should be strictly followed. It was recommended that these products be prepared and administered only by healthcare professionals familiar with these procedures.

Both proposed changes were considered acceptable and were incorporated into the Product Monograph.

Based on the safety data reviewed in this submission, the benefit-harm-uncertainty profile of Zeulide Depot remains unchanged when used according to its approved indications.

For further details about Zeulide Depot, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.