Questcor Pharmaceuticals Inc. (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 or sNDA to market H.P. Acthar Gel, or repository corticotrophin injection, for the treatment of infantile spasms or IS. The FDA has set the user fee goal date or PDUFA of June 11, 2010 for this sNDA.
The company said that 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.
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