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The manufacturer, Pfizer Canada Inc. has resubmitted to pCODR for Crizotinib (Xalkori) Advanced NSCLC. Please see the Crizotinib (Xalkori) for Advanced NSCLC Resubmission Details page for more information.
|Project Number||pCODR 10008|
|Strength||200mg and 250mg|
|Indication||Advanced Non-Small Cell Lung Cancer|
|Funding Request||Patients with anaplastic lymphoma kinase-(ALK) positive advanced non-small cell lung cancer (NSCLC).|
|Review Status||Notification to Implement Issued (Original Submission Complete)|
|Pre Noc Submission||Yes|
|NOC Date||April 25, 2012|
|Manufacturer||Pfizer Canada Inc.|
|Sponsor||Pfizer Canada Inc.|
|Submission Date||March 26, 2012|
|Submission Deemed Complete||April 11, 2012|
|Submission Type||New Drug|
|Prioritization Requested||Not Requested|
|Stakeholder Input Deadline ‡||April 11, 2012|
|Check-point meeting||May 23, 2012|
|pERC Meeting||July 19, 2012|
|Initial Recommendation Issued||August 2, 2012|
|Feedback Deadline ‡||August 17, 2012|
|pERC Reconsideration Meeting||September 20, 2012|
|Final Recommendation Issued||October 4, 2012|
|Notification to Implement Issued||October 22, 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.