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cysteamine bitartrate

Last Updated: November 8, 2017
Result type: Reports
Project Number: SR0526-000
Product Line: Common Drug Review

Generic Name: cysteamine bitartrate

Brand Name: Procysbi

Manufacturer: Horizon Pharma

Indications: Nephropathic cystinosis

Submission Type: New

Project Status: Active

Biosimilar: No

Fee Schedule1: Schedule A

Key Milestones2

Call for patient input posted3June 05, 2017
Patient group input closed3July 25, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsSeptember 12, 2017
Patient group comments on input summary closedSeptember 18, 2017
Clarification:

- Patient input summary feedback received

Submission receivedAugust 08, 2017
Submission accepted for reviewAugust 22, 2017
Review initiatedAugust 23, 2017
Draft CDR review report(s) sent to applicantNovember 07, 2017
Comments from applicant on draft CDR review report(s) receivedNovember 16, 2017
Redaction requests from applicant on draft CDR review report(s) receivedNovember 23, 2017
CDR review team's comments on draft CDR review report(s) sent to applicantDecember 01, 2017
Canadian Drug Expert Committee (CDEC) meetingDecember 13, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJanuary 02, 2018
To
January 04, 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

genetics, pediatrics, cysteamine, cystinosis, delayed-action preparations, Procysbi; cysteamine bitartrate; cystinosis; delayed release; sustained release; extended release; nephropathic; delayed action; controlled release; time release