cysteamine bitartrate

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 posted³	05-Jun-17
Patient group input closed³	25-Jul-17
Clarification: - Patient input submission received
Patient input summary sent for review to patient input groups	12-Sep-17
Patient group comments on input summary closed	18-Sep-17
Submission received	08-Aug-17
Submission accepted for review	22-Aug-17
Review initiated	23-Aug-17
Draft CDR review report(s) sent to applicant	07-Nov-17
Comments from applicant on draft CDR review report(s) received	16-Nov-17
Redaction requests from applicant on draft CDR review report(s) received	23-Nov-17
CDR review team's comments on draft CDR review report(s) sent to applicant	01-Dec-17
Canadian Drug Expert Committee (CDEC) meeting	13-Dec-17
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans	January 2, 2018 To January 4, 2018

Refer to Appendix 1 of the Procedure for the CADTH Common Drug Review for details regarding CDR application fee schedules.
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.
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.
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).
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.
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.

Key Milestones2