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CLARIFICATION: The manufacturer, GlaxoSmithKline Inc. has resubmitted to pCODR for Pazopanib Hydrochloride (Votrient) submission. Please see the Pazopanib hydrochloride (Votrient) for Metastatic Renal Cell Carcinoma Resubmission Details page for more information.
| Project Number | pCODR 10000 |
|---|---|
| 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 who have a Memorial Sloan Kettering Prognostic Score of Favourable or Intermediate Risk |
| Review Status | Notification to Implement Issued (Resubmission Complete) |
| Pre Noc Submission | No |
| NOC Date | May 27, 2010 |
| Manufacturer | GlaxoSmithKline Inc. |
| Sponsor | GlaxoSmithKline Inc. |
| Submission Date | July 14, 2011 |
| Submission Deemed Complete | July 21, 2011 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | July 28, 2011 |
| Check-point meeting | September 2, 2011 |
| pERC Meeting | October 20, 2011 |
| Initial Recommendation Issued | November 3, 2011 |
| Feedback Deadline ‡ | November 18, 2011 |
| pERC Reconsideration Meeting | December 15, 2011 |
| Final Recommendation Issued | January 5, 2012 |
| Notification to Implement Issued | January 20, 2012 |
‡ 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.
