Last Updated : February 26, 2025
Details
FilesGeneric Name:
clascoterone
Project Status:
Active
Therapeutic Area:
Acne vulgaris
Manufacturer:
Sun Pharma Canada Inc.
Call for patient/clinician input open:
Brand Name:
Winlevi
Project Line:
Reimbursement Review
Project Number:
SR0863-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the first-line prescription topical treatment of moderate and severe acne vulgaris in patients 12 years of age and older.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the topical treatment of acne vulgaris in patients 12 years of age and older.
Recommendation Type:
Do not reimburse
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
| 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 CADTH review report(s) provided to sponsor for comment | August 23, 2024 |
| Deadline for sponsors comments | August 30, 2024 |
| CADTH 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 CADTH review report(s) | February 21, 2025 |
| CADTH review report(s) posted | - |
Files
Last Updated : February 26, 2025