Last Updated : December 21, 2018
Details
FilesGeneric Name:
dexamethasone
Project Status:
Complete
Therapeutic Area:
Diabetic macular edema
Manufacturer:
Allergan Inc.
Call for patient/clinician input open:
Brand Name:
Ozurdex
Project Line:
Reimbursement Review
Project Number:
SR0535-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule B
Indications:
Diabetic macular edema
Date NOC Issued:
Recommendation Type:
Do not reimburse
Final Recommendation:
Key Milestones2 |
|
|---|---|
| Call for patient input posted | August 25, 2017 |
| Patient group input closed | October 17, 2017 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | October 24, 2017 |
| Patient group comments on input summary closed | October 31, 2017 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | September 26, 2017 |
| Submission accepted for review | October 13, 2017 |
| Clarification:
- Submission was not accepted for review on 2017 Oct 11 - Revised category 1 requirements received on 2017 Oct 13 |
|
| Review initiated | October 16, 2017 |
| Draft CDR review report(s) sent to applicant | January 05, 2018 |
| Comments from applicant on draft CDR review report(s) received | January 16, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | January 23, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | February 08, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | February 21, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | March 06, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | April 18, 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 | November 08, 2018 |
Files
Last Updated : December 21, 2018