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cysteamine bitartrate

Last Updated: April 19, 2018
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: Complete

Biosimilar: No

Date Recommendation Issued: January 24, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

Key Milestones2

Call for patient input postedJune 05, 2017
Patient group input closedJuly 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 03, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedJanuary 17, 2018
CDEC Final Recommendation issued to applicant and drug plansJanuary 24, 2018
CDEC Final Recommendation postedJanuary 26, 2018
Final CDR review report(s) and patient input postedFebruary 08, 2018

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