Generic Name: fluticasone propionate / salmeterol xinafoate
Brand Name: Arbesda RespiClick
Manufacturer: TEVA Canada Innovation
Therapeutic Area: Asthma
Indications: Asthma
Submission Type: Initial
Project Status: Complete
Biosimilar: No
Date Recommendation Issued: December 19, 2018
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule C
Key Milestones2 | |
|---|---|
| Call for patient input posted | September 05, 2017 |
| Patient group input closed | October 25, 2017 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | April 18, 2018 |
| Patient group comments on input summary closed | April 25, 2018 |
| Clarification: - Patient input summary feedback received | |
| Submission received | October 04, 2017 |
| Submission accepted for review | February 20, 2018 |
| Clarification: - Submission was not accepted for review on 19 Oct 2017 - Revised category 1 requirements received on 14 Feb 2018 | |
| Review initiated | February 28, 2018 |
| Draft CADTH review report(s) sent to applicant | May 23, 2018 |
| Comments from applicant on draft CADTH review report(s) received | June 08, 2018 |
| Redaction requests from applicant on draft CADTH review report(s) received | June 15, 2018 |
| CADTH review team's comments on draft CADTH review report(s) sent to applicant | July 06, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | July 18, 2018 |
| CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans | July 31, 2018 |
| Embargo period ended and validation of redacted CADTH review report(s) received | September 13, 2018 |
| Clarification: - Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested | |
| Applicant's request for reconsideration placed on CDEC agenda | December 12, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | December 19, 2018 |
| CDEC Final Recommendation posted | December 21, 2018 |
| Final CADTH review report(s) and patient input posted | January 17, 2019 |