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Rilutek: Market
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In clinical trials, Rilutek extended survival in people with ALS for about three months, although it wasn't shown to improve symptoms or slow muscle deterioration. Company representatives from RPR appeared before the panel to present data and argue that Rilutek should be recommended for approval by the FDA - a necessary step before any drug can be marketed.
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RILUZOLE (Rilutek®) slows down the progression of amyotrophic lateral sclerosis (... known as Lou Gehrig's disease). Riluzole helps to delay the loss of muscle strength and limb function for several months; it is not a cure. It can slow the loss of respiratory function. Generic riluzole tablets are approved, but are not yet marketed in the US.
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The families listened and waited tensely for the decision, which would help determine if Rilutek was to hit the market soon or if more clinical study would be necessary. Rilutek was at a crossroads, but as with other drugs that companies wish to bring to market, the journey had begun years before - in the laboratory.
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