Last Updated : November 17, 2023
Details
Generic Name:
clascoterone
Project Status:
Withdrawn
Therapeutic Area:
Acne vulgaris
Manufacturer:
Sun Pharma Canada Inc.
Call for patient/clinician input open:
Brand Name:
Winlevi
Project Line:
Reimbursement Review
Project Number:
SR0786-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For
first-line prescription topical treatment of moderate and severe acne vulgaris
in patients 12 years of age and older.
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | 23-May-23 |
|---|---|
| Call for patient/clinician input closed | 14-Jul-23 |
| Clarification: - Patient input submission received from the Acne and Rosacea Society of Canada and Canadian Skin Patient Alliance | |
| Submission received | 04-Jul-23 |
| Submission accepted | 18-Jul-23 |
| Review initiated | 19-Jul-23 |
| Draft CADTH review report(s) provided to sponsor for comment | 04-Oct-23 |
| Deadline for sponsors comments | 16-Oct-23 |
| CADTH review report(s) and responses to comments provided to sponsor | 09-Nov-23 |
| Clarification: - Voluntarily withdrawn by the sponsor on 15 Nov 2023 | |
Last Updated : November 17, 2023