Regulatory Decision Summary for Cilostazol (*ZETPLIYA)

Decision issued

No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.

Date of cancellation

July 14, 2022

What was the purpose of this submission?

The purpose of this New Drug Submission (NDS) was to obtain market authorization for Zetpliya (cilostazol), proposed for the improvement of maximal and pain-free walking distance in patients with intermittent claudication, secondary to peripheral artery disease, in whom lifestyle modifications have failed.

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, clinical and non-clinical data packages, as well as labelling information and a post-market Risk Management Plan.

What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?

At the time of the cancellation, the review of the submission was ongoing. Health Canada identified some deficiencies in the package that would have precluded issuing an approval. Health Canada issued a Notice of Deficiency for this product on December 24, 2021 to the sponsor and was awaiting a response to it. The sponsor chose to cancel their submission prior to sending the 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 in clinical trials or patients using SAP.

Additional information

*Proposed Brand Name:

Zetpliya