October 19, 2009 (FinancialWire) — Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR) has resubmitted its filing to the U.S. Food & Drug Administration  for its supplemental New Drug Application  seeking approval to market H.P. Acthar(R) Gel (repository corticotrophin injection) for the treatment of infantile spasms. The resubmission follows the FDA’s request in May 2009 for the filing to include additional statistical analysis relating to data from one secondary study within the company’s filing.

Acthar is currently approved in the U.S. for the treatment of MS exacerbations, nephrotic syndrome and many other conditions. Acthar is not approved in the U.S. for the treatment of IS, a potentially life-threatening disorder that typically begins in the first year of life. However, pursuant to guidelines published by the American Academy of Neurology and the Child Neurology Society, many child neurologists use Acthar to treat infants afflicted with this condition. Questcor is currently pursuing FDA approval for Acthar in the treatment of IS. Previously, the FDA granted Orphan Designation to Acthar for the treatment of IS.

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