Last Updated : January 22, 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.
- 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 Canada's Drug Agency review report(s) provided to sponsor for comment | August 23, 2024 |
| Deadline for sponsors comments | August 30, 2024 |
| Canada's Drug Agency 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 |
Files
Last Updated : January 22, 2025