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Questcor Submits Supplemental New Drug Application to FDA for H.P. Acthar(r) Gel for Treatment of Infantile Spasms
UNION CITY, Calif., March 17, 2009 (GLOBE NEWSWIRE) -- Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR) 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.