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Advisory Committee Recommends Reintroduction of Tysabri to Market
The Committee's recommendation is advisory to the FDA, and the agency is not bound by this recommendation. The FDA has designated TYSABRI for Priority Review, a status for products that are considered to be significant therapeutic advancements over existing therapies that address an unmet medical need. Biogen Idec and Elan will continue to work closely with the FDA in the weeks ahead with the goal of making TYSABRI available. Discussions with FDA will include, among other things, finalizing the details of the TYSABRI risk management plan. The companies anticipate action by the FDA by March 29, 2006.
Source: Biogen Idec and Elan Corporation