Questcor refiles sNDA for H.P. Acthar Gel
Tuesday, December 02 2008 | Comments
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Questcor Pharmaceuticals Inc. resubmitted a supplemental New Drug Application (sNDA) for its injectable H.P. Acthar gel (corticotrophin) in the treatment of infantile spasms. The firm originally submitted the sNDA in June 2006, but the Food and Drug Administration notified the company in May 2007 that the sNDA was not approvable in the form submitted. Questcor did not provide specific details regarding the FDA's nonapprovable letter.
Since then, Questcor has worked with the regulatory agency "to gather and present necessary data to support the sNDA," explained Don Bailey, chief executive officer.
H.P. Acthar gel, a natural adrenocorticotropic hormone, is approved to treat acute exacerbations of multiple sclerosis, among other indications.
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