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nitisinone

Last Updated: November 20, 2017
Result type: Reports
Project Number: SR0538-000
Product Line: Common Drug Review

Generic Name: nitisinone

Brand Name: MDK-Nitisinone

Manufacturer: MendeliKABS Inc

Indications: Hereditary tyrosinemia type 1

Project Status: Active

Biosimilar: No

Fee Schedule1: Schedule A

Key Milestones2

Call for patient input posted3August 31, 2017
Patient group input closed3October 23, 2017
Clarification:

- Patient input submission received

Submission receivedSeptember 29, 2017
Submission accepted for reviewOctober 16, 2017
Review initiatedOctober 20, 2017
Draft CDR review report(s) sent to applicantJanuary 10, 2018
Comments from applicant on draft CDR review report(s) receivedJanuary 19, 2018
Redaction requests from applicant on draft CDR review report(s) receivedJanuary 26, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantMarch 09, 2018
Canadian Drug Expert Committee (CDEC) meetingMarch 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansApril 03, 2018
To
April 05, 2018

Tags

digestive system, genetics, pediatrics