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New official approval of Questcor Pharmaceuticals’ Acthar gel, which treats infantile spasms in multiple sclerosis patients, will take more time because of delays over the wording of the label and medication guide.
Acthar has been used for decades but Questcor is seeking fresh confirmation from the US Food and Drug Administration.
The company said it does not know when the department will complete its review.
Labelling on the gel’s packaging has not been changed since 1978, when it was passed by the department to treat flare-ups experienced by people with MS.
Questcor meanwhile said third-quarter sales of Acthar are set to exceed those of 2010’s second quarter.
Copyright Press Association 2010
US Food and Drug Administration
