Posts tagged ‘acthar’

ACTHAR

By September 11, 2010, the FDA must decide on the approvability of ACTHAR (corticotropin gel) for the treatment of certain types of infantile spasms.  Following a very positive May 11, 2010 Advisory Committee recommendation, the FDA imposed a 3 month delay on the original PDUFA Date of June 11, 2010 to allow them to work on labeling issues and refine a REMS program for the drug with the sponsor, Questcor.  It seems reasonable to believe that the FDA action will be positive, considering the experience the company has with this drug.