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Votrient for metastatic renal cell carcinoma - Resubmission - Details

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 PC0022-000
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 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
Therapeutic Area Metastatic Renal Cell Carcinoma
Recommendation Type Reimburse

‡ 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.