OTHER DOCUMENT

As of: 11/23/14 6:59 PM

Docket: FDA-2013-P-0025
Refrain from Approving Any New Drug for the Treatment of Multiple Sclerosis Unless & Until It Has Been Reviewed by the Approprite Advisory Committee-CLOSED

Document: FDA-2013-P-0025-0001
Teva Pharmaceutical Industries Ltd. - Citizen Petition


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Teva Pharmaceutical Industries Ltd Citizen Petition

Exhibit 1 Public Health Advisory Suspended Marketing of Tysabri

Exhibit 2 New Risk Factor for Progressive Multifocal Leukoencephalopathy Associated with Tysabri natalizumab

Exhibit 3 FDA Approves Resumed Marketing of Tysabri Under a Special Distribution Program

Exhibit 4 Package Insert for Tysabri

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Exhibit 5 Safety Review of a Reported Death After the First Dose of Multiple Sclerosis Drug Gilenya

Exhibit 6 Package Insert for Gilenya

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Exhibit 7 Product Labeling for Panoplin

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