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glycopyrrolate

Last Updated: July 6, 2020
Result type: Reports
Project Number: SR0613-000
Product Line: Common Drug Review

Generic Name: glycopyrrolate

Brand Name: Cuvposa

Manufacturer: MEDEXUS Pharmaceuticals, Inc.

Indications: chronic severe drooling, neurologic (pediatric)

Manufacturer Requested Reimbursement Criteria1: Cuvposa (glycopyrrolate) is indicated to reduce chronic severe drooling in patients aged 3-18 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).

Submission Type: New

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: June 24, 2020

Recommendation Type: Do not reimburse

Fee Schedule: Schedule A

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedApril 11, 2019
Patient group input closedJune 03, 2019
Clarification:

- No patient input submission received

Submission receivedMay 31, 2019
Submission acceptedJune 14, 2019
Review initiatedJune 24, 2019
Draft CADTH review report(s) sent to sponsorSeptember 16, 2019
Comments from sponsor on draft CADTH review report(s) receivedSeptember 25, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorNovember 08, 2019
Canadian Drug Expert Committee (CDEC) meetingNovember 20, 2019
CDEC recommendation sent to sponsor and drug plansDecember 04, 2019
Embargo period endedJanuary 23, 2020
Clarification:

- Embargo extension granted

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agendaJune 17, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansJune 24, 2020
CDEC Final Recommendation postedJune 26, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedJuly 09, 2020
Clarification:

- No redactions requested by the sponsor

Final CADTH review report(s) posted-