The manufacturer, GlaxoSmithKline Inc. has resubmitted to pCODR for the Pazopanib Hydrochloride (Votrient) submission. Please see the Pazopanib hydrochloride (Votrient) for Metastatic Renal Cell Carcinoma Details page for information pertaining to the original submission.
| Project Number | pCODR 10022 |
|---|---|
| Brand Name | Votrient |
| Generic Name | Pazopanib hydrochloride |
| Strength | 200 mg |
| Tumour Type | Genitourinary |
| Indication | Metastatic Renal Cell Carcinoma |
| Funding Request | First-line therapy in patients with metastatic renal cell (clear cell) carcinoma with good performance status (ECOG 0-1) |
| Review Status | Notification to Implement Issued (Original Submission Complete) |
| Pre Noc Submission | No |
| NOC Date | May 27, 2010 |
| Manufacturer | GlaxoSmithKline Inc. |
| Sponsor | GlaxoSmithKline Inc. |
| Submission Date | February 20, 2013 |
| Submission Deemed Complete | March 6, 2013 |
| Submission Type | Resubmission |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | March 6, 2013 |
| Check-point meeting | April 24, 2013 |
| pERC Meeting | June 20, 2013 |
| Initial Recommendation Issued | July 5, 2013 |
| Feedback Deadline ‡ | July 19, 2013 |
| pERC Reconsideration Meeting | August 15, 2013 |
| Final Recommendation Issued | August 29, 2013 |
| Notification to Implement Issued | September 16, 2013 |
‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.
