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Last Updated: March 12, 2018
Result type: Reports
Project Number: SR0535-000
Product Line: Common Drug Review

Generic Name: dexamethasone

Brand Name: Ozurdex

Manufacturer: Allergan Inc.

Indications: Diabetic macular edema

Submission Type: New Indication

Project Status: Active

Biosimilar: No

Fee Schedule: Schedule B

Key Milestones2

Call for patient input postedAugust 25, 2017
Patient group input closedOctober 17, 2017

- Patient input submission received

Patient input summary sent for review to patient input groupsOctober 24, 2017
Patient group comments on input summary closedOctober 31, 2017

- Patient input summary feedback received

Submission receivedSeptember 26, 2017
Submission accepted for reviewOctober 13, 2017

- Submission was not accepted for review on 2017 Oct 11

- Revised category 1 requirements received on 2017 Oct 13

Review initiatedOctober 16, 2017
Draft CDR review report(s) sent to applicantJanuary 05, 2018
Comments from applicant on draft CDR review report(s) receivedJanuary 16, 2018
Redaction requests from applicant on draft CDR review report(s) receivedJanuary 23, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantFebruary 08, 2018
Canadian Drug Expert Committee (CDEC) meetingFebruary 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansMarch 06, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedApril 18, 2018

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted


eye, dexamethasone, diabetic retinopathy, diabetes, Ozurdex; DME; diabetic macular edema; diabetic macular oedema