Last Updated : November 14, 2024
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 | 24-Jun-24 |
|---|---|
| Call for patient/clinician input closed | 19-Aug-24 |
| Submission received | 06-Aug-24 |
| Submission accepted | 20-Aug-24 |
| Review initiated | 21-Aug-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 23-Aug-24 |
| Deadline for sponsors comments | 30-Aug-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 13-Sep-24 |
| Expert committee meeting (initial) | 25-Sep-24 |
| Draft recommendation issued to sponsor | 08-Oct-24 |
| Draft recommendation posted for stakeholder feedback | 17-Oct-24 |
| End of feedback period | 31-Oct-24 |
| Clarification: - Reconsideration: major revisions requested by sponsor - Target CDEC reconsideration meeting date to be determined . | |
Files
Last Updated : November 14, 2024