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fluticasone furoate/vilanterol

Last Updated: December 14, 2017
Result type: Reports
Project Number: SR0524-000
Product Line: Common Drug Review

Generic Name: fluticasone furoate/vilanterol

Brand Name: Breo Ellipta

Manufacturer: GlaxoSmithKline Inc.

Indications: COPD

Submission Type: Resubmission

Project Status: Withdrawn

Biosimilar: No

Key Milestones2

Call for patient input posted3May 31, 2017
Patient group input closed3July 20, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJuly 25, 2017
Patient group comments on input summary closedAugust 01, 2017
Clarification:

- Patient input summary feedback received

Submission receivedJune 28, 2017
Submission accepted for reviewJuly 13, 2017
Review initiatedJuly 14, 2017
Draft CDR review report(s) sent to applicantSeptember 28, 2017
Comments from applicant on draft CDR review report(s) receivedOctober 10, 2017
Redaction requests from applicant on draft CDR review report(s) receivedOctober 17, 2017
CDR review team's comments on draft CDR review report(s) sent to applicantNovember 03, 2017
Clarification:

- Voluntarily withdrawn by the manufacturer on 2017-Nov-09

Tags

copd, pulmonary disease, chronic obstructive, Chronic obstructive pulmonary disease; COPD