The company sNDA has been granted priority review status by the FDA and it was based on the results of a three-week monotherapy trial in 403 pediatric patients, of whom 302 received asenapine.
Actavis Global Brands R&D senior vice-president David Nicholson said: "The sNDA filing of SAPHRIS speaks to our commitment to ongoing research and development of our mental health portfolio.
"We are pleased that the FDA has accepted this sNDA, marking the first step towards our goal of bringing this important antipsychotic treatment option to pediatric patients."
The company expects the Prescription Drug User Fee Act (PDUFA) date to be in the first quarter of 2015.
During the trial, asenapine was shown to be statistically superior to placebo in the reductions of both the Young Mania Rating Scale (YMRS) total score and Clinical Global Impression-Bipolar (CGI-BP) score at fixed doses of 2.5mg, 5mg and 10mg twice daily.
The most commonly observed adverse reactions were somnolence, dizziness, dysgeusia, oral hypoesthesia, oral paresthesia, nausea, increased appetite, fatigue and increased weight.