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news.Questcor Pharmaceuticals, a specialty pharmaceutical company, has resubmitted to the FDA its supplemental new drug application seeking approval to market HP Acthar gel for the treatment of infantile spasms.
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Acthar (repository corticotropin injection) 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 due to lupus erythamatosus.
In June 2006 Questcor submitted a supplemental new drug application (sNDA) to the FDA and in May 2007 the FDA determined that the sNDA was not approvable in the form submitted in 2006. Subsequently, Questcor met with the FDA to review the company’s plans for resubmission.
Don Bailey, president and CEO of Questcor, said: “We have worked closely with the FDA for the past 18 months to gather and present necessary data to support the sNDA and we look forward to working with the FDA during the review process of our resubmission.”