Teva Pharmaceutical Industries Ltd. - Citizen Petition

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Teva Pharmaceutical Industries Ltd Citizen Petition

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Exhibit 1 Public Health Advisory Suspended Marketing of Tysabri

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

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

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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

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Exhibit 6 Package Insert for Gilenya

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Exhibit 7 Product Labeling for Panoplin

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Comment Period Closed
ID: FDA-2013-P-0025-0001

Document Information

Date Posted: Jan 9, 2013
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Submitter Information

Country: United States
Category: Private Industry - C0003

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