FOCALIN XR (dexmethylphenidate hydrochloride)
Focalin XR is a central nervous system stimulant used for Attention Deficit Hyperactivity Disorder (ADHD). It helps patients with this condition manage their symptoms and is typically prescribed for adults and children at least 6 years of age. It is not recommended for younger children because they may experience higher drug exposure and an increased risk of side effects like weight loss.
How FOCALIN XR Works
Focalin XR works as a central nervous system stimulant. While it is used to manage symptoms, the specific way the drug produces its therapeutic effects in patients with ADHD is currently unknown.
Details
- Status
- Prescription
- First Approved
- 2005-05-26
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
FOCALIN XR Approval History
What FOCALIN XR Treats
1 indicationsFOCALIN XR is approved for 1 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Attention Deficit Hyperactivity Disorder
FOCALIN XR Boxed Warning
ABUSE, MISUSE, AND ADDICTION F ocalin XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Focalin XR, can result in overdose and death [see Overdosage ( 10 )] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing Focalin XR, assess each patient’s risk for abuse, misuse, and addiction. Educat...
WARNING: ABUSE, MISUSE, AND ADDICTION F ocalin XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Focalin XR, can result in overdose and death [see Overdosage ( 10 )] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing Focalin XR, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout Focalin XR treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 )]. WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. Focalin XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Focalin XR, can result in overdose and death ( 5.1 , 9.2 , 10 ). • Before prescribing Focalin XR, assess each patient’s risk for abuse, misuse, and addiction. • Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. • Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
FOCALIN XR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to FOCALIN XR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FOCALIN XR FDA Label Details
Indications & Usage
FDA Label (PDF)FOCALIN XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder.
WARNING: ABUSE, MISUSE, AND ADDICTION F ocalin XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Focalin XR, can result in overdose and death [see Overdosage ( 10 )] , and th...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.