Last Updated : April 25, 2025
Details
Procedural review: Canada’s Drug Agency has accepted a Procedural Review request from Sun Pharma Canada Inc. for the SR0863 clascoterone Canadian Drug Expert Committee (CDEC) final recommendation.
The drug programs and the pan-Canadian Pharmaceutical Alliance (pCPA) have been informed of this status change.
Procedural Review decision due: June 19, 2025
| Call for patient/clinician input open | June 24, 2024 |
|---|---|
| Call for patient/clinician input closed | August 19, 2024 |
| Submission received | August 06, 2024 |
| Submission accepted | August 20, 2024 |
| Review initiated | August 21, 2024 |
| Draft CDA-AMC review report(s) provided to sponsor for comment | August 23, 2024 |
| Deadline for sponsors comments | August 30, 2024 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | September 13, 2024 |
| Expert committee meeting (initial) | September 25, 2024 |
| Draft recommendation issued to sponsor | October 08, 2024 |
| Draft recommendation posted for stakeholder feedback | October 17, 2024 |
| End of feedback period | October 31, 2024 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | January 22, 2025 |
| Final recommendation issued to sponsor and drug plans | February 06, 2025 |
| Final recommendation posted | February 25, 2025 |
| Deadline for sponsor to submit redaction requests on draft CDA-AMC review report(s) | February 21, 2025 |
| CDA-AMC review report(s) posted | - |
| Procedural Review accepted | April 14, 2025 |
| Procedural Review under way, decision due | June 19, 2025 |