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Actavis’s supplemental New Drug Application (sNDA) for asenapine (Saphris) to treat manic or mixed episodes related to bipolar disorder in pediatric patients has been accepted by the FDA and given priority review status. According to Actavis, Saphris has been prescribed more than 1 million times since it was first approved by the FDA in 2009. If the FDA expands that approval, the drug would also be used for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients 10 to 17 years of age.

Compared with placebo, those who took twice-daily dosages . . .

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