Posted in Tysabri • Tags: Advisers, Drug, Endorse, FDA, Multiple, of, Return, Sclerosis, Tysabri
03.08.06, 12:00 AM ET
WEDNESDAY, March 8 (HealthDay News) — A U.S. Food and Drug Administration advisory panel voted unanimously Wednesday to allow the promising but controversial multiple sclerosis drug Tysabri back on the market.
The advisers continued to discuss certain controls on who could use the drug, which has been linked to a rare but potentially fatal brain infection. The panel members agreed to a manufacturer plan for a mandatory patient registry; they were scheduled to decide later in the day who would be allowed to enroll in the registry, and how tightly drug use would be limited, the Associated Press reported.
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Posted on March 22, 2006 by HART (1-800-HART) • There are no comments, hop to it!
Posted in Tysabri • Tags: Tysabri
By Associated Press
March 10, 2006
WASHINGTON - A multiple sclerosis drug pulled from the market a year ago because of a rare but life-threatening side effect is on track to return - but with some strong restrictions on how it’s used.
Advisers to the Food and Drug Administration have unanimously recommended that the government let Tysabri’s manufacturers resume sales - but only to patients enrolled in a mandatory registry designed to track, if not minimize, the risk of a rare brain infection linked to the drug.
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Posted on March 13, 2006 by HART (1-800-HART) • There are no comments, hop to it!
