Questcor Submits Supplemental New Drug Application to FDA for H.P. Acthar(r) Gel for Treatment of Infantile Spasms

Questcor Pharmaceuticals, Inc. announced that it has completed its filing to the U.S. Food & Drug Administration (FDA) for its supplemental New Drug Application (sNDA) seeking approval to market H.P. Acthar(r) Gel (repository corticotrophin injection) for the treatment of infantile spasms. In June 2006 Questcor submitted a 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.

"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," said Don M. Bailey, President and CEO of Questcor.

Source : www.msnbc.msn.com

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