Generic Name: ozenoxacin
Brand Name: Ozanex
Manufacturer: Ferrer Internacional, S.A.
Therapeutic Area: Impetigo
Indications: Impetigo
Manufacturer Requested Reimbursement Criteria1: For the topical treatment of impetigo in patients aged 2 months and older.
Submission Type: Initial
Project Status: Complete
Biosimilar: No
Companion Diagnostics: No
Date Recommendation Issued: October 24, 2018
Recommendation Type: Do not reimburse
Fee Schedule: Schedule A
- 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.
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 |