FDA Approves Clonidine HCl for ADHD

Shionogi & Co. Oct. 4 announced that the Food and Drug Administration has approved Kapvay (clonidine hydrochloride) extended-release tablets for the treatment of attention deficit hyperactivity disorder in children and adolescents six to 17 years old.

Kapvay is the only formulation of clonidine hydrochloride approved by the FDA for the treatment of ADHD, and is the first and only FDA-approved ADHD treatment indicated for use as add-on therapy to stimulant medication, the Osaka, Japan-based company said. Kapvay also can be used as monotherapy when treating ADHD.

An oral, nonstimulant, twice-daily therapy, Kapvay is a centrally acting alpha2-adrenergic receptor agonist, Shionogi ...