Friday, June 11, 2010

Questcor Pharma's (QCOR) shares likely to drop on after-market announcement of FDA's extension

Questcor Receives Notification of PDUFA Date Extension to September 11, 2010

UNION CITY, Calif., June 11, 2010 /PRNewswire via COMTEX News Network/ -- Questcor Pharmaceuticals, Inc. (Nasdaq: QCOR) today announced that it has received notification from the U.S. Food & Drug Administration (FDA) that the PDUFA date for Questcor's supplemental new drug application (sNDA) to approve Acthar for the treatment of infantile spasms (IS) has been extended to September 11, 2010. The FDA extended the PDUFA date in order to review information regarding labeling and potential post-approval commitments that they solicited from Questcor. This follows the May 6, 2010 votes by the Advisory Committee to the Division of Peripheral and Central Nervous System Drugs of the FDA which indicated support for approval of this new Acthar indication.

"We look forward to working with the FDA over the next few months in order to finalize these critical elements," said Don M. Bailey, President and CEO of Questcor.

Investors should note that there can be no assurance that the FDA will approve this sNDA by September 11, 2010, or thereafter.

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