October 18, 2010 (FinancialWire) (http://www.financialwire.net/) –  Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR) said that the U.S. Food and Drug Administration has approved Questcor's supplemental new drug application for H.P. Acthar Gel in the treatment of infantile spasms, an ultra-rare orphan disorder affecting around 2,000 American children annually.

IS is a potentially life-threatening form of epilepsy seen in infancy and early childhood.  

Acthar is already widely used by pediatric neurologists to treat IS based on guidelines published by the American Academy of Neurology and Child Neurology Society.

In conjunction with approval of the IS indication, and as a result of the FDA's orphan designation for Acthar in the treatment of IS, the FDA has also granted Acthar a seven-year exclusivity period during which the FDA is prohibited from approving any other adrenocorticotropic hormone formulation for IS unless the other formulation is demonstrated to be clinically superior to Acthar.

Also, along with the approval notice the FDA has approved a new Acthar label and has finalized a medication guide for Acthar in the treatment of IS.

Acthar was originally approved by the FDA in 1952. Prior to the modernization of the Acthar label in connection with FDA approval of the sNDA the label included over 50 approved indications.

Other than the indications for MS exacerbations and nephrotic syndrome, Questcor did not expect to generate any meaningful net sales in the next several years from any of these legacy indications.

California-based Questcor is a biopharmaceutical company.

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