Onyda XR FDA Approval History
Last updated by Carmen Pope, BPharm on June 19, 2024.
FDA Approved: Yes (First approved May 24, 2024)
Brand name: Onyda XR
Generic name: clonidine hydrochloride
Dosage form: Extended-Release Suspension
Company: Tris Pharma, Inc.
Treatment for: ADHD
Onyda XR (clonidine hydrochloride) is a once-daily, extended-release, oral suspension that may be used to treat attention-deficit/hyperactivity disorder (ADHD) in children aged six years and older.
- Onyda XR is the first liquid non-stimulant ADHD medication to be approved in the United States and the only approved non-stimulant ADHD medication with nighttime dosing.
- ADHD is a common neurobehavioral disorder with an onset in childhood. Symptoms include inappropriate and maladaptive inattentiveness, impulsivity, and hyperactivity, resulting in impairment in family, social, academic, and occupational functioning.
- Onyda XR be used as monotherapy or in addition to approved central nervous system (CNS) stimulants.
- Non-stimulant ADHD therapies are an important option for patients who do not respond adequately to stimulant medication or experience negative side effects from them.
- Tris Pharma harnessed the flexibility of its proprietary LiquiXR® technology to develop Onyda XR, which allows for once-daily dosing.
- The U.S. FDA approval of Onyda XR is based on adequate and well-controlled studies of clonidine hydrochloride extended-release tablets.
Development timeline for Onyda XR
| Date | Article |
|---|---|
| May 30, 2024 | Approval FDA Approves Onyda XR (clonidine hydrochloride) Non-Stimulant Liquid Treatment for ADHD |
Further information
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