Generic Name: fluticasone furoate/vilanterol
Brand Name: Breo Ellipta
Manufacturer: GlaxoSmithKline Inc.
Submission Type: Resubmission
Project Status: Withdrawn
|Call for patient input posted3||May 31, 2017|
|Patient group input closed3||July 20, 2017|
- Patient input submission received
|Patient input summary sent for review to patient input groups||July 25, 2017|
|Patient group comments on input summary closed||August 01, 2017|
- Patient input summary feedback received
|Submission received||June 28, 2017|
|Submission accepted for review||July 13, 2017|
|Review initiated||July 14, 2017|
|Draft CDR review report(s) sent to applicant||September 28, 2017|
|Comments from applicant on draft CDR review report(s) received||October 10, 2017|
|Redaction requests from applicant on draft CDR review report(s) received||October 17, 2017|
|CDR review team's comments on draft CDR review report(s) sent to applicant||November 03, 2017|
- Voluntarily withdrawn by the manufacturer on 2017-Nov-09
- Refer to Appendix 1 of the Procedure for the CADTH Common Drug Review for details regarding CDR application fee schedules.
- Please refer to the Procedure for the CADTH Common Drug Review for complete details regarding the CDR process and targeted time frames for key milestones.
- The call for patient group input is posted 20 business days in advance of the applicant's anticipated date of filing the CDR application. Patient groups have a total of 35 business days for preparing and submitting patient input.
- The embargoed CDEC recommendation is held in confidence by all stakeholders and not acted upon until after CADTH has issued the notice of CDEC Final Recommendation.The applicant may make a request for reconsideration or resubmission based on reduced price during the embargo period, and the drug plans may make a request for clarification, as applicable (see section 8 of the Procedure for the CADTH Common Drug Review).
- The timing for posting the CDEC Final Recommendation and CDR review report(s) depends on several factors including the need for consultation with the applicant regarding redaction issues.
- The time frame required to address a request for clarification at the drug plans' request or request for reconsideration at the applicant's request depends on the amount of work required to address the request and the available dates for CDEC meetings.
copd, pulmonary disease, chronic obstructive, Chronic obstructive pulmonary disease; COPD