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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 12, 2009
QUESTCOR PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
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California
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001-14758
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33-0476164 |
(State or Other Jurisdiction
of Incorporation)
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(Commission File Number)
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(I.R.S. Employer
Identification No.) |
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3260 Whipple Road, Union City, California
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94587 |
(Address of Principal Executive Offices)
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(Zip Code) |
Registrants telephone number, including area code: (510) 400-0700
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c)) |
TABLE OF CONTENTS
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. Acthar® 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.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date: May 13, 2009 |
QUESTCOR PHARMACEUTICALS, INC.
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By: |
/s/
Gary M. Sawka
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Gary M. Sawka |
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Senior Vice President,
Finance and Chief Financial Officer |
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