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FDA Approves H.P. Acthar Gel for the Treatment of Infantile Spasms

Posted 18 Oct 2010 by Drugs.com

ANAHEIM, Calif., Oct. 15 /PRNewswire-FirstCall/ – Questcor Pharmaceuticals, Inc. (Nasdaq: QCOR) today announced the U.S. Food and Drug Administration (FDA) has approved Questcor's supplemental new drug application (sNDA) for H.P. Acthar Gel (repository corticotropin injection) in the treatment of infantile spasms (IS), an ultra-rare orphan disorder affecting approximately 2,000 American children annually. IS is a devastating and potentially life-threatening form of epilepsy seen in infancy and early childhood. "The approval of Acthar for infantile spasms is an example of Questcor's clear focus on helping patients with serious, difficult-to-treat medical conditions," said Don M. Bailey, president and CEO of Questcor. "Today's approval is an important milestone for babies afflicted with IS, as well as the doctors, nurses and parents who care for them. The FDA approval of Acthar for IS ... Read more

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