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MS Drug, Tysabri, to be Available with Restrictions

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At a glance:

The FDA has cautiously reapproved a controversial multiple sclerosis drug, Tysabri. 
 
The drug was withdrawn in February 2005 because of complications: some patients developed a rare brain infection called progressive multifocal leukoencephalopathy (PML) which caused severe disability or death. 
 
After months of study, the drug will soon be available for MS that is relapsing, with stringent controls and educational programs for doctors and patients.

Relapsing multiple sclerosis: FDA has approved the reintroduction ...

Xagena.it - 6/5/2006 6:18 PM

The FDA ( U.S. Food and Drug Administration ) has approved the reintroduction of Tysabri (Natalizumab) as a monotherapy treatment for relapsing forms of multiple sclerosis to slow the progression of disability and reduce the frequency of clinical relapses.
 
TYSABRI will be available upon the completion of key activities related to the risk management plan (TOUCH Prescribing Program), including FDA review of educational and training materials, internal validation of systems based on final FDA requirements and training of internal personnel
 
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