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Questcor: FDA Delays Drug Approval
Questcor announced late Wednesday that the U.S. Food and Drug Administration has delayed for the second time an approval decision for the company's drug Acthar as a treatment for infantile spasms.
A new approval date has not been announced but Questcor said FDA's review will extend beyond the current Sept. 11 deadline because regulators need more time to finalize the wording on the label, review the proposed medication guide, and define post-approval commitments, if any, for the infantile spasms indication.
