December 28, 2009 (FinancialWire) — Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR) announced the U.S. Food & Drug Administration now considers that Questcor has provided a complete response to all prior action letters for its supplemental New Drug Application to market H.P. Acthar(R) Gel (repository corticotrophin injection) for the treatment of infantile spasms. The FDA has set the user fee goal date (PDUFA) of June 11, 2010 for this sNDA.

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. Previously, the FDA granted Orphan Designation to Acthar for the treatment of IS.

Questcor Pharmaceuticals, Inc. is a pharmaceutical company that markets H.P. Acthar(R) Gel (repository corticotropin injection). H.P. Acthar Gel (Acthar) is an injectable drug that is approved for the treatment of certain disorders with an inflammatory component, including the treatment of exacerbations associated with multiple sclerosis and to induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that is due to lupus erythamatosus.

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