APTENSIO XR
Details
- Status
- Prescription
- First Approved
- 2015-04-17
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
APTENSIO XR Approval History
What APTENSIO XR Treats
1 indicationsAPTENSIO XR is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Attention Deficit Hyperactivity Disorder
APTENSIO XR Boxed Warning
ABUSE, MISUSE, AND ADDICTION APTENSIO 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 APTENSIO 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 APTENSIO XR, assess each patient's risk for abuse, misuse, and addiction. Educa...
WARNING: ABUSE, MISUSE, AND ADDICTION APTENSIO 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 APTENSIO 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 APTENSIO 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 APTENSIO 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) and Drug Abuse and Dependence (9.2) ] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. Aptensio 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 APTENSIO XR, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing APTENSIO 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.
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Active Pipeline
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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.
APTENSIO XR FDA Label Details
ProIndications & Usage
FDA Label (PDF)APTENSIO XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD ) in patients 6 years and older [see Clinical Studies ]. APTENSIO XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Limitations of Use : The use of Aptensio XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. Limitations of ...
WARNING: ABUSE, MISUSE, AND ADDICTION APTENSIO 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 APTENSIO 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.