Regulatory Decision Summary for Bisoprolol fumarate (*JAMP BISOPROLOL)
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: bisoprolol fumarate (*JAMP BISOPROLOL)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation
September 16, 2020
What was the purpose of this submission?
This New Drug Submission (NDS) was filed to obtain market authorization for Jamp Bisoprolol (2.5, 5 and 10 milligrams (mg) tablets) for the management of patients with mild to moderate hypertension. The sponsor was seeking authorization of the 2.5 mg dose, which, unlike the other two proposed doses, is not currently authorized for use in Canada therefore requiring the filing on an NDS.
What did the company submit to support its submission?
The company provided drug quality data and results from a bioequivalence study. They did not provide clinical evidence to support the efficacy of the 2.5 milligram (mg) dose for the treatment of mild to moderate hypertension.
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 cancellation, the review of the submission was nearing completion. Health Canada had identified deficiencies in the data submitted in support of the New Drug Submission (NDS). The sponsor chose to cancel their submission following discussions with Health Canada.
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:
Jamp Bisoprolol