Questcor Pharmaceuticals Inc. (QCOR) said the FDA has extended the PDUFA date for Questcor's supplemental new drug application for Acthar to September 11.
The FDA extended the PDUFA date in order to review information regarding labeling and potential post-approval commitments that they solicited from Questcor.
Hence, the company noted that there can be no assurance that the FDA will approve its sNDA by September 11, 2010, or thereafter.
Earlier, in May, the FDA advisory committee indicated support for approval of this new Acthar indication for the treatment of infantile spasms.
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