Last Updated : November 6, 2019
Details
FilesGeneric Name:
ulipristal acetate
Project Status:
Complete
Therapeutic Area:
Uterine fibroids (signs and symptoms)
Manufacturer:
Allergan Inc.
Call for patient/clinician input open:
Brand Name:
Fibristal
Project Line:
Reimbursement Review
Project Number:
SF0609-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Submission Type:
Request For Advice
Indications:
Uterine fibroids (signs and symptoms)
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
Key Milestones1 |
|
|---|---|
| Call for patient input posted | March 29, 2019 |
| Patient group input closed | May 21, 2019 |
| Clarification:
- Patient input submission received from CANFib (Canadian Women with Fibroids Incorporated) and the Womenâs Health Initiative Network |
|
| Patient input summary sent for review to patient input groups | May 14, 2019 |
| Patient group comments on input summary closed | May 21, 2019 |
| Clarification:
- Patient input summary feedback received |
|
| Request for Advice received | March 28, 2019 |
| Manufacturer informed of request for advice | March 28, 2019 |
| Manufacturer information or comments due | April 11, 2019 |
| Request for Advice initiated | April 12, 2019 |
| Draft CDR Request for Advice report sent to manufacturer | May 09, 2019 |
| Comments from manufacturer on draft CDR Request for Advice report received | May 21, 2019 |
| Redaction requests from manufacturer on draft CDR Request for Advice report received | May 28, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | June 19, 2019 |
| CDEC recommendation & redacted CDR Request for Advice report sent to manufacturer and drug plans | July 03, 2019 |
| Embargo period ended and validation of redacted CDR Request for Advice report received | July 17, 2019 |
| CDEC Final Recommendation issued to manufacturer and drug plans | July 24, 2019 |
| CDEC Final Recommendation posted | July 30, 2019 |
| Final CDR review report(s) posted | August 01, 2019 |
Files
Last Updated : November 6, 2019