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Last Updated: November 27, 2018
Result type: Reports
Project Number: SR0535-000
Product Line: Reimbursement Review

Generic Name: dexamethasone

Brand Name: Ozurdex

Manufacturer: Allergan Inc.

Therapeutic Area: Diabetic macular edema

Indications: Diabetic macular edema

Submission Type: Initial

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: October 24, 2018

Recommendation Type: Do not reimburse

Fee Schedule: Schedule B

Key Milestones2

Call for patient input posted August 25, 2017
Patient group input closed October 17, 2017

- 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

- Patient input summary feedback received

Submission received September 26, 2017
Submission accepted for review October 13, 2017

- 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

- 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