Begin main content


Last Updated: February 15, 2018
Result type: Reports
Project Number: SR0531-000
Product Line: Common Drug Review

Generic Name: nitisinone

Brand Name: Orfadin

Manufacturer: Sobi Canada Inc.

Indications: Hereditary tyrosinemia type 1

Submission Type: New

Project Status: Active

Biosimilar: No

Fee Schedule1: Schedule A

Key Milestones2

Call for patient input posted3July 28, 2017
Patient group input closed3September 19, 2017

- Patient input submission received

Patient input summary sent for review to patient input groupsOctober 05, 2017
Patient group comments on input summary closedOctober 13, 2017

- Patient input summary feedback received

Submission receivedAugust 29, 2017
Submission accepted for reviewSeptember 13, 2017
Review initiatedSeptember 14, 2017
Draft CDR review report(s) sent to applicantNovember 27, 2017
Comments from applicant on draft CDR review report(s) receivedDecember 06, 2017
Redaction requests from applicant on draft CDR review report(s) receivedDecember 13, 2017
CDR review team's comments on draft CDR review report(s) sent to applicantJanuary 05, 2018
Canadian Drug Expert Committee (CDEC) meetingJanuary 17, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJanuary 30, 2018
Embargo4 period ended and validation of redacted CDR review report(s) receivedFebruary 13, 2018
CDEC Final Recommendation issued to applicant and drug plansFebruary 21, 2018
CDEC Final Recommendation posted5-
Final CDR review report(s) and patient input posted5-
  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.


digestive system, genetics, pediatrics, tyrosinemias, nitisinone; tyrosinemia