The company claims that SAPHRIS is the only atypical antipsychotic treatment option with a sublingual (under the tongue) formulation.
The NDA is based on the results of a three-week monotherapy trial in 403 pediatric patients, of which 302 pediatric patients received SAPHRIS twice daily in doses of either 2.5mg, 5mg or 10mg.
In the US, around 1.2 million children and teens meet the criteria for bipolar I disorder, who experience mood episodes ranging from manic episodes, depressive episodes, or mixed episodes.
Actavis executive vice president Global R&D David Nicholson said: "We were pleased to see that SAPHRIS was effective across a range of doses, in the largest registrational pediatric trial for an atypical antipsychotic in bipolar I disorder.
"SAPHRIS is the first atypical antipsychotic to be approved for pediatric patients with bipolar I disorder in the last five years.
"As part of our commitment to mental health, we look forward to making this treatment option available to patients as soon as possible."
According to the company, consumption of SAPHRIS showed improvement in Young Mania Rating Scale (YMRS) total score and Clinical Global Impression-Bipolar (CGI-BP) Severity of Illness overall score versus placebo in a pediatric clinical trial.
In the second quarter of 2015, SAPHRIS will be available for pediatric patients with bipolar I disorder in 2.5mg, 5mg and 10mg black cherry flavour sublingual tablets.