Last Updated : March 20, 2023
Details
Generic Name:
ferumoxytol
Project Status:
Withdrawn
Therapeutic Area:
Iron deficiency anemia
Manufacturer:
Covis Pharma Canada Ltd.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0753-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron.
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | August 03, 2022 |
|---|---|
| Call for patient/clinician input closed | September 23, 2022 |
| Clarification: - Patient input submission received from the Gastrointestinal Society | |
| Submission received | August 31, 2022 |
| Submission accepted | September 15, 2022 |
| Review initiated | September 16, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | November 30, 2022 |
| Deadline for sponsors comments | December 09, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | January 13, 2023 |
| Expert committee meeting (initial) | January 25, 2023 |
| Clarification: - CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements. - Withdrawn by the sponsor on 20 Mar 2023 | |
Last Updated : March 20, 2023