FDA Accepts sNDA for Vyvanse; Sunovion Submits sNDAs for Latuda

The Food and Drug Administration had accepted for review a supplemental new drug application for Vyvanse and Sunovion Pharmaceuticals has filed two sNDAs for Latuda (lurasidone hydrochloride).

On Sept. 12, Shire Plc announced that FDA has accepted for review its supplemental new drug application for Vyvanse (lisdexamfetamine dimesylate) capsules.

Shire is seeking approval of Vyvanse as a maintenance treatment in children and adolescents ages 6 to 17 years of age with attention-deficit/hyperactivity disorder (ADHD). There currently are no stimulants approved for this indication, the Dublin, Ireland-based company said.

FDA has issued a Prescription Drug User Fee Act (PDUFA) action date ...