Actavis' sNDA accepted by FDA for Saphris in bipolar I disorder

Ireland-headquartered generics major Actavis (NYSE: ACT) has had its Supplemental New Drug Application  for Saphris (asenapine) for the acute treatment of manic or mixed episodes in bipolar I disorder in pediatric patients, aged 10-17 accepted by the US Food and Drug Administration.

The sNDA has been granted priority review status by the FDA.

David Nicholson, senior vice president of Actavis global brands R&D, 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."