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fluticasone propionate

Last Updated: September 20, 2018
Result type: Reports
Project Number: SR0539-000
Product Line: Common Drug Review

Generic Name: fluticasone propionate

Brand Name: Aermony RespiClick

Manufacturer: TEVA Canada Innovation

Indications: Asthma

Submission Type: New

Project Status: Active

Biosimilar: No

Fee Schedule: Schedule A

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 groupsMarch 29, 2018
Patient group comments on input summary closedApril 06, 2018
Clarification:

- Patient input summary feedback received

Submission receivedOctober 04, 2017
Submission accepted for reviewOctober 19, 2017
Review initiatedFebruary 20, 2018
Clarification:

- Initiation was delayed at the request of the manufacturer

Draft CDR review report(s) sent to applicantMay 16, 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

- Target CDEC reconsideration meeting date to be determined

Tags

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