Last Updated : December 21, 2018
Details
FilesGeneric Name:
ozenoxacin
Project Status:
Complete
Therapeutic Area:
Impetigo
Manufacturer:
Ferrer Internacional, S.A.
Brand Name:
Ozanex
Project Line:
Reimbursement Review
Project Number:
SR0553-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the topical treatment of impetigo in patients aged 2 months and older.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Impetigo
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.
Key Milestones2 |
|
|---|---|
| Call for patient input posted | December 14, 2017 |
| Patient group input closed | February 09, 2018 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | February 13, 2018 |
| Patient group comments on input summary closed | February 21, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | January 25, 2018 |
| Submission accepted for review | February 08, 2018 |
| Review initiated | February 13, 2018 |
| Draft CDR review report(s) sent to applicant | April 30, 2018 |
| Comments from applicant on draft CDR review report(s) received | May 09, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | May 16, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | June 08, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | June 20, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | July 05, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | August 17, 2018 |
| Clarification:
- Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested |
|
| Applicant's request for reconsideration placed on CDEC agenda | October 17, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | October 24, 2018 |
| CDEC Final Recommendation posted | October 26, 2018 |
| Final CDR review report(s) and patient input posted | October 29, 2018 |
Files
Last Updated : December 21, 2018