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news.Questcor Pharmaceuticals, a provider of prescription drugs for central nervous system disorders, has completed its filing with the FDA for its supplemental new drug application seeking approval to market HP Acthar Gel for the treatment of infantile spasms.
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In June 2006 Questcor submitted a supplemental new drug application (sNDA) to the FDA and in May 2007 the FDA determined 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.”