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fluocinolone acetonide

Last Updated: January 24, 2018
Result type: Reports
Project Number: SR0549-000
Product Line: Common Drug Review

Generic Name: fluocinolone acetonide

Brand Name: Iluvien

Manufacturer: Knight Therapeutics Inc.

Indications: Diabetic macular edema (DME)

Submission Type: New

Project Status: Active

Biosimilar: No

Fee Schedule1: Schedule A

Key Milestones2

Call for patient input posted3 November 22, 2017
Patient group input closed3 January 18, 2018
Clarification:

- No patient input submission received

Submission received December 21, 2017
Submission accepted for review January 12, 2018
Review initiated January 15, 2018
Draft CDR review report(s) sent to applicant March 29, 2018
Comments from applicant on draft CDR review report(s) received April 10, 2018
Redaction requests from applicant on draft CDR review report(s) received April 17, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant May 04, 2018
Canadian Drug Expert Committee (CDEC) meeting May 16, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans May 29, 2018
To
May 31, 2018
  1. Refer to Appendix 1 of the Procedure for the CADTH Common Drug Review for details regarding CDR application fee schedules.
  2. Please refer to the Procedure for the CADTH Common Drug Review for complete details regarding the CDR process and targeted time frames for key milestones.
  3. The call for patient group input is posted 20 business days in advance of the applicant's anticipated date of filing the CDR application. Patient groups have a total of 35 business days for preparing and submitting patient input.
  4. The embargoed CDEC recommendation is held in confidence by all stakeholders and not acted upon until after CADTH has issued the notice of CDEC Final Recommendation.The applicant may make a request for reconsideration or resubmission based on reduced price during the embargo period, and the drug plans may make a request for clarification, as applicable (see section 8 of the Procedure for the CADTH Common Drug Review).
  5. The timing for posting the CDEC Final Recommendation and CDR review report(s) depends on several factors including the need for consultation with the applicant regarding redaction issues.
  6. The time frame required to address a request for clarification at the drug plans' request or request for reconsideration at the applicant's request depends on the amount of work required to address the request and the available dates for CDEC meetings.

Tags

eye, diabetes