ot-Tysabri

[Guest guest]

Tysabri®: The FDA Wants to Hear From People with MSThe US Food and Drug Administration would like to hear fromindividuals who have MS about how they feel about Tysabri(natalizumab, sponsored by Biogen Idec and Elan Corporation).Tysabri was withdrawn in February 2005 due to safety concerns and iscurrently being re-evaluated by the FDA. (Read backgroundinformation about Tysabri.)One of the roles of the FDA's Office of Special Health Issues is toserve as a channel through which patient issues and viewpoints canbe brought to the attention of FDA medical and regulatory staff.The drug's sponsors have requested a priority review of theirapplication, which, if granted by the FDA, would result in FDAaction within an estimated six months from the late September 2005submission date, rather than the 10 months expected for a standardreview.If you or someone you know has MS and would like to express youropinion about the fate of Tysabri, contact:Mail: Office of Special Health IssuesFood and Drug AdministrationHF-12, Room 9-495600 Fishers LaneRockville, MD 20857 Phone: (301) 827-4460 or toll-free 888-INFOFDA (888-463-6332)Fax: (301) 443-4555E-mail: OSHI@...Note: The Office of Special Health Issues cannot comment on thestatus of a product undergoing FDA review. They are also not theplace to request information about adverse events or productproblems. You may visit MedWatch area on the FDA's Web site forinformation about reporting these events. Updated November 3, 2005