Actavis: FDA Approves SAPHRIS - Quick Facts

(RTTNews) - Actavis plc (ACT) announced the U.S. FDA has approved its supplemental new drug application (sNDA) for SAPHRIS (asenapine) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients. SAPHRIS will be available for pediatric patients with bipolar I disorder in 2.5 mg, 5 mg and 10 mg black cherry flavor sublingual tablets in the second quarter of 2015.

The company said SAPHRIS is the only atypical antipsychotic treatment option with a sublingual (under the tongue) formulation. The FDA approval of SAPHRIS is based on the results of a 3-week monotherapy trial in 403 pediatric patients.