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fluticasone propionate / salmeterol xinafoate

Last Updated: December 21, 2018
Result type: Reports
Project Number: SR0540-000
Product Line: Common Drug Review

Generic Name: fluticasone propionate / salmeterol xinafoate

Brand Name: Arbesda RespiClick

Manufacturer: TEVA Canada Innovation

Indications: Asthma

Submission Type: New Combination

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 postedSeptember 05, 2017
Patient group input closedOctober 25, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsApril 18, 2018
Patient group comments on input summary closedApril 25, 2018
Clarification:

- Patient input summary feedback received

Submission receivedOctober 04, 2017
Submission accepted for reviewFebruary 20, 2018
Clarification:

- Submission was not accepted for review on 19 Oct 2017

- Revised category 1 requirements received on 14 Feb 2018

Review initiatedFebruary 28, 2018
Draft CDR review report(s) sent to applicantMay 23, 2018
Comments from applicant on draft CDR review report(s) receivedJune 08, 2018
Redaction requests from applicant on draft CDR review report(s) receivedJune 15, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantJuly 06, 2018
Canadian Drug Expert Committee (CDEC) meetingJuly 18, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJuly 31, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedSeptember 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 agendaDecember 12, 2018
CDEC Final Recommendation issued to applicant and drug plansDecember 19, 2018
CDEC Final Recommendation postedDecember 21, 2018
Final CDR review report(s) and patient input postedJanuary 17, 2019

Tags

asthma, dry powder inhalers, respiratory, respiclick; arbesda; fluticasone propionate; salmeterol; dry powder inhaler; asthmatic; asthmatics