Comeback Begins for Tysabri

Updated from June 5

The official word has come down, and Tysabri is going back on the market, but U.S. regulators determined that the label for the multiple sclerosis drug will have to carry their strongest type of cautionary statement.

Biogen Idec and Elan (ELN Quote), the marketers of Tysabri, said Monday that the Food and Drug Administration has approved the product's return after a 16-month absence.

However, the drug's label will also contain what's called a black box warning because Tysabri was linked to a potentially fatal brain disease last year. The agency also recommended the drug be prescribed for patients who haven't responded well to other MS therapies or who can't tolerate other options. ...