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dexamethasone

Last Updated: December 13, 2017
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 Schedule1: Schedule B

Key Milestones2

Call for patient input posted3August 25, 2017
Patient group input closed3October 17, 2017
Clarification:

- 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
Clarification:

- Patient input summary feedback received

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

- 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 04, 2018
Comments from applicant on draft CDR review report(s) receivedJanuary 15, 2018
Redaction requests from applicant on draft CDR review report(s) receivedJanuary 22, 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 05, 2018
To
March 07, 2018

Tags

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