Actavis' sNDA for Saphris approved by FDA

16 March 2015

The US Food and Drug Administration has approved the supplemental New Drug Application for Saphris (asenapine), from Ireland-headquartered generics major Actavis (NYSE: ACT).

Saphris has been approved as a monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in children, and will be made available for these patients in 2.5mg, 5mg and 10mg sublingual tablets in the second quarter of 2015. Actavis has said that the drug is the only atypical antipsychotic treatment available as a sublingual formulation.

The approval is based on the results of a three-week trial of Saphris as a monotherapy in 403 pediatric patients.

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