Generic Name: nitisinone
Brand Name: MDK-Nitisinone
Manufacturer: MendeliKABS Inc
Therapeutic Area: Hereditary tyrosinemia type 1
Indications: Hereditary tyrosinemia type 1
Submission Type: Initial
Project Status: Complete
Biosimilar: No
Date Recommendation Issued: April 25, 2018
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule A
Key Milestones2 | |
|---|---|
| Call for patient input posted | August 31, 2017 |
| Patient group input closed | October 23, 2017 |
| Clarification: - Patient input submission received | |
| Submission received | September 29, 2017 |
| Submission accepted for review | October 16, 2017 |
| Review initiated | October 20, 2017 |
| Draft CDR review report(s) sent to applicant | January 24, 2018 |
| Comments from applicant on draft CDR review report(s) received | February 02, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | February 09, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | March 21, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | April 04, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | April 18, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | April 25, 2018 |
| CDEC Final Recommendation posted | April 27, 2018 |
| Final CDR review report(s) and patient input posted | April 27, 2018 |