Onyda XR Extended-Release Suspension Approved for ADHD

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The Food and Drug Administration (FDA) has approved Onyda XR (clonidine hydrochloride) extended-release oral suspension for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older.

Onyda XR, a centrally acting alpha2-adrenergic agonist, was approved based on adequate and well-controlled studies of clonidine hydrochloride extended-release tablets. The non-stimulant treatment is administered once daily at bedtime.  

When switching from another clonidine product, patients should discontinue that treatment, and titrate with Onyda XR using the titration schedule. Onyda XR should not be substituted for other clonidine products on a mg-per-mg basis because of differing pharmacokinetic profiles.

Onyda XR is supplied as an extended-release suspension for oral administration containing 0.1mg of clonidine hydrochloride per mL in a 120mL bottle. The orange-flavored suspension is expected to be available in the second half of 2024. 



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