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dexamethasone

Last Updated: April 25, 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 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

- Target CDEC reconsideration meeting date to be determined

Tags

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