Shionogi gets FDA approval for Kapvay

FLORHAM PARK, N.J. The Food and Drug Administration has approved a nonstimulant drug for treating attention deficit hyperactivity disorder.


Shionogi announced Monday the approval of Kapvay (clonidine hydrochloride), an extended-release drug for treating ADHD in children and adolescents ages 6 to 17 years. The company said Kapvay was the only formulation of clonidine hydrochloride approved for treating ADHD and the first ADHD treatment approved for use as an add-on therapy to stimulant drugs.



“The FDA approval of Kapvay represents an exciting milestone in the field of ADHD,” Shionogi chief medical officer Donald Manning said. “We look forward to providing this important, beneficial treatment for ADHD to patients, both as monotherapy and add-on therapy to stimulants.”


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