Wednesday, Questcor Pharmaceuticals, Inc. (QCOR) said that the U.S. Food and Drug Administration or FDA has informed the company that it will require additional time beyond the current action date of September 11 to complete its review of Questcor's supplemental new drug application or sNDA for H.P. Acthar Gel or repository corticotropin injection in the treatment of infantile spasms.
In conjunction with the FDA's review of this sNDA, Questcor and the agency have been updating and modernizing the product label for Acthar, which has not been modified since 1978, when multiple sclerosis was added to the label.
The company said that this step of the review process is now complete and that the FDA needs additional 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.
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