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Darunavir/cobicistat/emtricitabine/tenofovir alafenamide

Last Updated: January 16, 2018
Result type: Reports
Project Number: SR0552-000
Product Line: Common Drug Review

Generic Name: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide

Brand Name: TBC

Manufacturer: Janssen Inc.

Indications: HIV-1 infection

Submission Type: New

Project Status: Active

Biosimilar: No

Fee Schedule1: Schedule C

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Key Milestones2

Call for patient input posted3November 24, 2017
Patient group input closed3January 22, 2018
Patient input summary sent for review to patient input groups-
Patient group comments on input summary closed-
Submission receivedDecember 22, 2017
Submission accepted for reviewJanuary 15, 2018
Review initiatedJanuary 16, 2018
Draft CDR review report(s) sent to applicantApril 02, 2018
Comments from applicant on draft CDR review report(s) receivedApril 11, 2018
Redaction requests from applicant on draft CDR review report(s) receivedApril 18, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantJune 08, 2018
Canadian Drug Expert Committee (CDEC) meetingJune 20, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJuly 03, 2018
July 05, 2018
  1. Refer to Appendix 1 of the Procedure for the CADTH Common Drug Review for details regarding CDR application fee schedules.
  2. 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.
  3. 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.
  4. 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).
  5. 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.
  6. 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.


infectious diseases, hiv/aids