CDA | Evidence Driven
CDA | Evidence Driven

clascoterone

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Withdrawn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.
  1. 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.
Key Milestones2
Call for patient/clinician input open23-May-23
Call for patient/clinician input closed14-Jul-23
Clarification:

- Patient input submission received from the Acne and Rosacea Society of Canada and Canadian Skin Patient Alliance

Submission received04-Jul-23
Submission accepted18-Jul-23
Review initiated19-Jul-23
Draft CADTH review report(s) provided to sponsor for comment04-Oct-23
Deadline for sponsors comments16-Oct-23
CADTH review report(s) and responses to comments provided to sponsor09-Nov-23
Clarification:

- Voluntarily withdrawn by the sponsor on 15 Nov 2023

Last Updated : November 17, 2023