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QCOR > SEC Filings for QCOR > Form 8-K on 13-May-2009All Recent SEC Filings

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Form 8-K for QUESTCOR PHARMACEUTICALS INC


13-May-2009

Other Events


Item 8.01 Other Events.
On May 12, 2009, Questcor Pharmaceuticals, Inc. was informed by the U.S. Food & Drug Administration (FDA) that for its supplemental New Drug Application (sNDA) seeking approval to market H.P. ActharŽ Gel (repository corticotropin injection) for the treatment of infantile spasms to be considered a Complete Response, Questcor must perform additional statistical analyses relating to data from one study within the filing, and provide the data generated from these analyses to the FDA. Questcor intends to conduct these analyses and update the sNDA filing as soon as practical.


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