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The FDA has approved Novartis’ Exelon (rivastigmine tartrate) for the treatment of mild to moderate Parkinson's disease dementia, making it the first approved medication available for the treatment of this condition. Exelon was previously approved for use in the treatment of Alzheimer's disease.
Cephalon said the FDA has rejected its approval bid for its developmental attention deficit hyperactivity disorder drug Sparlon (modafinil). As a result, Cephalon will not pursue further development of Sparlon, the company said. The decision comes after an FDA advisory committee earlier this year voted 12 to 1 to reject Cephalon’s Sparlon application, recommending the company provide additional information about a link to a rare and potentially deadly skin disorder called Stevens-Johnson syndrome. The FDA is not required to follow the advice of its advisory committees, but usually does.